BARD SILICONE CHANNEL DRAIN

Report

Report Number: 1018233-2010-00110
Event Type: Injury
Date Received: November 11, 2010
Date of Event: September 27, 2010
Report Date: October 14, 2010
Manufacturer: C.R. BARD, INC.
Product Code: GBX
PMA / PMN Number: EXEMPT
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NC, US
Reporter Occupation: RISK MANAGER

Narratives

Additional Manufacturer Narrative · 1

THE SAMPLE WAS NOT RETURNED FOR EVALUATION. WITHOUT A LOT NUMBER, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. HOWEVER, A REVIEW OF THE MANUFACTURING PROCESS DID NOT FIND ANY RELATED ISSUES THAT COULD CAUSE OR CONTRIBUTE TO THIS FAILURE MODE. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE STATES THE FOLLOWING PRECAUTIONS TO AVOID THE POSSIBILITY OF DRAIN DAMAGE OR BREAKAGE. "AVOID SUTURING THROUGH DRAIN. DRAIN SHOULD LIE FLAT AND IN LINE WITH THE SKIN EXIT AREAS. PARTICULAR CARE SHOULD BE TAKEN TO AVOID ANY OBSTACLES TO THE DRAIN EXIT PATH. DRAIN SHOULD BE CHECKED FOR FREE MOTION DURING CLOSURE TO MINIMIZE THE POSSIBILITY OF BREAKAGE. DRAIN REMOVAL SHOULD BE DONE GENTLY BY HAND. DRAIN SHOULD NOT BE HANDLED WITH POINTED, TOOTHED OR SHARP INSTRUMENTS WHICH COULD CAUSE CUTS OR NICKS AND LEAD TO SUBSEQUENT STRUCTURAL FAILURE OF THE DRAIN. SURGICAL REMOVAL MAY BE NECESSARY IF DRAIN IS DIFFICULT TO REMOVE OR BREAKS. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED VIA A MEDWATCH REPORT THAT A DRAIN PLACED ON (B)(6) 2010 BROKE WHEN THE PHYSICIAN ATTEMPTED TO PULL IT FROM THE PATIENT'S ABDOMEN 6 DAYS LATER. THE RETAINED FRAGMENT RETRACTED REQUIRING SURGICAL REMOVAL. THE PHYSICIAN REPORTED THAT SHE DID NOT PULL THE DRAIN ANY HARDER THAN USUAL FOR REMOVING THESE DRAINS. NO ADDITIONAL INFORMATION COULD BE OBTAINED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	BARD SILICONE CHANNEL DRAIN		GBX	C.R. BARD, INC.	NA	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	66 YR		Required Intervention