RE: Lot number documentation

[Ann . Zonderman]

My legal side just has to offer --- if a problem arises with a product, SAVE IT - not just the lot number and model, but the actual product if at all possible.   it may help to show what happened and perhaps later be useful to help prevent future similar problems... it would become evidence for a lawsuit.

 

Years ago I dealt with a case of a fatal overdose of morphine which was being delivered via a pain pump.   My research found that the FDA Med Watch had an alert out on the pump due to a mechanical failure which led to inadvertent administration of extra doses.  The hospital "lost" the pump.  and therefore had no defense for the mishap..... 

 

Ann Zonderman 

 

 

-----Original Message-----
From: [EMAIL PROTECTED] [mailto:[EMAIL PROTECTED]On Behalf Of Barbera, Sara
Sent: Thursday, October 05, 2006 9:09 AM
To: Nancy Bagnall-Trick RN, CRNI; [EMAIL PROTECTED]; [EMAIL PROTECTED]
Subject: RE: Lot number documentation

You are correct, Nancy.  While I'd hate to speak for the quality folks in my organization, the lot number can pin down date of manufacture as well.  If you have ever had a problem with a catheter, I am sure you have heard the manufacturer's rep ask for not only the lot number, but the sample as well.  It may seem somewhat "messy" to keep the product around, but it is amazing what can be found out by having both the lot number and the product itself.  This may be something you want to keep in mind if you have a problem.  I think that it will resolve issues faster and allow for better patient care (from a device perspective) more quickly.

 

Sara MH Barbera

Senior Product Manager

Boston Scientific - Oncology

508-683-4257 (ph)

508-683-5568 (f)

[EMAIL PROTECTED]

 

---

From: Nancy Bagnall-Trick RN, CRNI [mailto:[EMAIL PROTECTED]
Sent: Thursday, October 05, 2006 12:04 PM
To: Barbera, Sara; [EMAIL PROTECTED]; [EMAIL PROTECTED]
Subject: RE: Lot number documentation

Also Sara, doesn't the Lot number help pin down the date the lot was produced?  In my Marketing Manager days, we utilized the lot number when screening for product occurrences and attempt to find any similarities/repeat reports on product lots. 

 It is amazing what can be done to track down/clarify concerns on the product side when clinicians partner with industry.  That is why on the clinical side we need to document the number and include sending back the product to the manufacturer when we have a concern.  At the end of the day, we all are committed to the highest level of patient safety as I know you are!

Nancy T


"Barbera, Sara" <[EMAIL PROTECTED]> wrote:

Susan -- As a manufacturer, we can tell you exactly what brand and size catheter the lot number represents.  I'm sure it is the same for Bard, Arrow, AngioDynamics, etc., but will let them confirm.

 

Sara MH Barbera

Senior Product Manager

Boston Scientific - Oncology

508-683-4257 (ph)

508-683-5568 (f)

[EMAIL PROTECTED]

 

---

From: [EMAIL PROTECTED] [mailto:[EMAIL PROTECTED] On Behalf Of [EMAIL PROTECTED]
Sent: Wednesday, October 04, 2006 4:47 PM
To: [EMAIL PROTECTED]
Subject: Lot number documentation

Several questions regarding lot numbers of PICC lines.

1--Are you documenting these in patient records?

2--Do you have a method to retrieve the numbers in the event of a recall ?(god forbid)  So you know which patients are affected? 

3--MANUFACTURERS--If I had just the lot number of a PICC, could you tell me the type and size etc of the catheter?

 

Thanks in advance!

 

--
Susan Schuetrumpf, CRNI
VASPRO
Atlanta, GA
cell-404-606-1194

Nancy Bagnall-Trick RN,CRNI
IV Resource Associates, Inc.
6592 Cortland Ave.
Brighton,MI 48114
Office: 517-546-4228
Mobil: 586-419-1777
[EMAIL PROTECTED]

This message and any included attachments are from IV Resource Associates, Inc. and are intended only for the addressee(s). If you receive this message in error, or have reason to believe you are not authorized to receive it, please promptly delete this message and advise the sender.

************************************************************* The information contained in this E-mail transmission is intended only for the use of the individual or entity to whom it is addressed. It may contain privileged, confidential, and protected health information. If you received it in error, you are on notice of its status. Please notify us immediately by reply e-mail and then please delete this message from your system. Please do not copy it or use it for any purposes, or disclose its contents to any other person. To do so could violate state and Federal privacy laws. Thank you for your cooperation. Please contact the sender if you need assistance.