BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVOL, INC.

    MDR report key: 3608 · Received December 29, 1992

    Report

    Report Number
    3608
    Event Type
    Malfunction
    Date Received
    December 29, 1992
    Date of Event
    June 22, 1992
    Report Date
    October 30, 1992
    Manufacturer
    BARD
    Product Code
    GCY
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    WHEN THE PORT-A-CATH WS REMOVED IN THE OPERATING ROOM, THE TUBING WAS NOT INTACT. THE TUBING WAS LATER RETRIEVED FROM THE IVC IN SPECIAL PROCEDURES IN RADIOLOGY. THE PORT-A-CATH IS IN THE O.R. BUSINESS MGR'S OFFICEINVALID 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.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: A DEVICE FROM SAME LOT WAS EVALUATED, VISUAL EXAMINATION. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. 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 HICKMAN DUAL LUMEN PORT-A-CATH GCY BARD 41 FADK 24R

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Other