FDA Adverse Event Malfunction Summary report: N

DAVOL, INC.

MDR report key: 3609 · Received December 29, 1992

Report

Report Number
3609
Event Type
Malfunction
Date Received
December 29, 1992
Date of Event
September 20, 1992
Report Date
October 30, 1992
Manufacturer
BARD
Product Code
LJT
Product Problem
Yes
Report Source
User Facility report

Narratives

Description of Event or Problem · 1

A FREE-FLOWING FOREIGN BODY WAS RETREIVED IN THE SPECIALS PROCEDURES AREA OF RADIOLOGY AND FOUND TO BE A PORTION OF A ORT-A-CATH CATHETER. ALTHOUGH I DO NOT HAVE THE COMPLETE INFORMATION AT THIS TIME, I BELIEVE IT WAS A GROSHONG CATHETER. I AM IN THE PROCESS OF LOCATING THE ID NUMBER OF THE PORT. I AM NOT SURE OF THE LOCATION OF THE RETREIVED CATHETER OR THE PORTINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. 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.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: MAYBE. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE, OTHER. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 DAVOL, INC. Implant PORT-A-CATH LJT BARD

Patients

Seq Age Sex Outcome Treatment
1 45 YR Other