FDA Adverse Event Malfunction Summary report: N

DAVOL

MDR report key: 9010 · Received July 29, 1994

Report

Report Number: 9010
Event Type: Malfunction
Date Received: July 29, 1994
Date of Event: March 25, 1994
Report Date: March 30, 1994
Manufacturer: DAVOL INC SUB C R BARD INC.
Product Code: LJT
Product Problem: Yes
Report Source: User Facility report

Narratives

Description of Event or Problem · 1

PATIENT WS SCHEDULED ON OUTPATIENT BASIS FOR "PLACEMENT OF HICKMAN CATHETER." PRIOR TO CATHETER AND PORT PLACEMENT, PORT AND PORTION (APPROX 10.5 CM) OF CATHETER (OF SAME TYPE TO BE PLACED) WERE EXPLANTED. PATIENT REPORTS THAT DISTAL END OF CATHETER HAD BROKEN OFF, HAD FLORATED INTO HER HEART AND WAS REMOVED THREE DAYS PRIOR (3/22/94) AT THE HOSPITAL CATHETERIZATION LABORATORY. PATIENT WAS NOT IN DISTRESS.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: . SERVICE PROVIDED BY: OTHER. SERVICE RECORDS NOT AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: VISUAL EXAMINATION. RESULTS OF EVALUATION: MATERIAL DEGRADATION/DETERIORATION, TELEMETRY FAILURE, TUBING. CONCLUSION: DEVICE FAILURE DIRECTLY CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: USE OF ALL SIMILAR DEVICES STOPPED TEMPORARILY. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	DAVOL Implant	HICKMAN PORT AND CATHETER	LJT	DAVOL INC SUB C R BARD INC.	UNKNOWN	UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1	68 YR		Other