FDA Adverse Event Malfunction Summary report: N

VTC BILIARY FIRM SYSTEM W/LOCKING PIGTAIL

MDR report key: 460 · Received April 8, 1992

Report

Report Number: 460
Event Type: Malfunction
Date Received: April 8, 1992
Date of Event: March 8, 1992
Report Date: March 13, 1992
Manufacturer: MEDI-TECH, INC.
Product Code: GCA
Product Problem: Yes
Report Source: User Facility report

Narratives

Description of Event or Problem · 1

BILIARY TUBE INSERTED ON 3/6/92 WITHOUT INCIDENT. TUBE BEGAN LEAKING ON 3/8/92. TUBE REPLACED 3/9/92. ON INSPECTION THE REMOVED TUBE SHOWED SEVERAL SPLITS IN THE WALL - CAUSING DISFUNCTION. DEFECT NOT PRESENT WHEN TUBE INSERTEDDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED. RESULTS OF EVALUATION: MANUFACTURING. CONCLUSION: DEVICE EVALUATED AND ALLEGED FAILURE COULD NOT BE DUPLICATED. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: MAYBE. CORRECTIVE ACTIONS: DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	VTC BILIARY FIRM SYSTEM W/LOCKING PIGTAIL Implant	N/A	GCA	MEDI-TECH, INC.	N/A	UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1	93 YR		Other