FDA Adverse Event Malfunction Summary report: N

ADD-EASE - CONNECTOR

MDR report key: 530073 · Received May 18, 2004

Report

Report Number: MW1032246
Event Type: Malfunction
Date Received: May 18, 2004
Date of Event: April 30, 2004
Report Date: May 18, 2004
Manufacturer: B BRAUN / MCGAW MEDICAL, INC.
Product Code: FPA
Product Problem: Yes
Report Source: Voluntary report
Reporter Location: IN, US
Reporter Occupation: PHARMACIST

Narratives

Description of Event or Problem · 1

ADD'L INFO REC'D FROM MFR 7/30/04: THE CONNECTED DEVICE HAS BEEN RETURNED TO B.BRAUN MEDICAL, INC. IRVINE, CA FOR EVALUATION. PREMATURE ACTIVATION (SELF RETRACTION OF THE PLUG) IS A CONDITION THAT IS VISIBLE TO THE CUSTOMER. HENCE, THE PRODUCT FAILS IN A WAY THAT DOES NOT CAUSE A SAFETY HAZARD; AS DETERMINED PER B. BRAUN MEDICAL, INC. PRODUCT SPECIFICATIONS. THIS REPORTED EVENT IS NOT STATED IN THE CURRENT LABELING; PREMATURE ACTIVATION IS NOT EXPECTED IF THE DEVICE IS USED PROPERLY PER THE INSTRUCTIONS. ROOM TEMPERATURE STORAGE OF THE CONNECTED UNITS IS RECOMMENDED AS AN ALTERNATIVE TO REFRIGERATION; REFERENCE B. BRAUN ADVERTISING STATUS NOTICE (ASN-3486). B. BRAUN IS COMMITTED TO THE DEVELOPMENT OF CLEAR AND CONCISE DIRECTIONS FOR USE FOR ALL PRODUCTS AND WILL CONTINUE TO WORK WITH CO'S SALES/TECHNICAL SERVICES GROUPS TO PROVIDE TECHNICAL TRAINING TO CO'S CUSTOMERS WHENEVER REQUIRED.

Description of Event or Problem · 1

MEDICATION (DAPTOMYIN) WAS CONNECTED TO A 100 ML BAG OF 0.9% NACL WITH AN ADD-BASE BINARY CONNECTOR. THIS WAS DELIVERED TO THE PT, WHO STORED IT IN THE REFRIGERATOR. WHEN THE PT REMOVED THE DOSE FROM THE REFRIGERATOR THEY FOUND IT HAD SELF RETRACTED. THEY CHOSE NOT TO USE IT AND RETURNED IT TO PHARMACIST.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ADD-EASE - CONNECTOR	BINARY CONNECTOR	FPA	B BRAUN / MCGAW MEDICAL, INC.	*	J6B105

Patients

Seq	Age	Sex	Outcome	Treatment
1	40 YR