BARCODE BLOOD BAND FOR HANDWRITING * 4R4610

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-04-11 for BARCODE BLOOD BAND FOR HANDWRITING * 4R4610 manufactured by Typenex Medical, Llc.

Event Text Entries

[3345604] Feedback from our post-partum obstetrical nursing manager that the typenex bracelets for mothers and their newborns are deteriorating. The plastic cellophane covering is peeling off. A new mother who was breast feeding became very alarmed when a small piece of the cellophane covering fell on to her breast while nursing her newborn. No patients have been harmed. The bracelets are in place for 1-3 days. These bands are used to identify individual patients and to match the correct mother to the correct infant. 1) post-partum unit collected 5 more examples of unacceptable bracelet. All bracelets were on patient for less than 3 days and deteriorated. All 5 bracelets were essentially illegible. 2) the product code 4r-46-10- confirmed lot (01)892159002024(10)m081612 typenex series hri as a problematic lot. There are other lots that have same problem, in particular lot with typenex series hse. ======================manufacturer response for typenex bracelet, barcode blood bank bands for handwriting catalog code -4r4680 yellow (per site reporter). ======================per e-mail from regional acct mgr, "please send the effected band samples to the address below included with my signature. Once we receive the bands we can complete testing and come up with reasons for why this is happening as well as next steps. I am not aware of any changes in material or production that have been made to your current band. It would be helpful if you can provide lot numbers associated with the bands. "what was the original intended procedure? Typenex bracelet. Device #1is this a laboratory device or laboratory test? No. Device #2is this a laboratory device or laboratory test? No.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3067725
• MDR Report Key: 3067725
• Date Received: 2013-04-11
• Date of Report: 2013-04-11
• Date of Event: 2013-04-04
• Report Date: 2013-04-11
• Date Reported to FDA: 2013-04-11
• Date Reported to Mfgr: 2013-04-19
• Date Added to Maude: 2013-04-19
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: BARCODE BLOOD BAND FOR HANDWRITING
• Generic Name: SUPPLIES, BLOOD-BANK
• Product Code: KSS
• Date Received: 2013-04-11
• Model Number: *
• Catalog Number: 4R4610
• Lot Number: M081612
• ID Number: *
• Device Availability: R
• Device Age: 1 DY
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: TYPENEX MEDICAL, LLC
• Manufacturer Address: 303 E WACKER DRIVE, STE #1200 CHICAGO IL 60601 US 60601

Device Sequence Number: 2

• Brand Name: BARCODE BLOOD BAND FOR HANDWRITING
• Generic Name: SUPPLIES, BLOOD-BANK
• Product Code: KSS
• Date Received: 2013-04-11
• Model Number: *
• Catalog Number: 4R4680
• Lot Number: *
• ID Number: *
• Device Availability: R
• Device Age: 1 DY
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: TYPENEX MEDICAL LLC
• Manufacturer Address: 303 E WACKER DRIVE, STE #1200 CHICAGO IL 60601 US 60601

Patients

Patient Number	Treatment	Outcome	Date
1	0		2013-04-11