BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAUD-A KATH CATHETER

    MDR report key: 21074 · Received March 15, 1995

    Report

    Report Number
    21074
    Event Type
    Malfunction
    Date Received
    March 15, 1995
    Report Date
    March 15, 1995
    Manufacturer
    EPI-MED
    Product Code
    GCB
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    PATIENT IN PRONE POSITION, AFTER PROCEDURE COMPLETED CATHETER & NEEDLE PULLED TOGETHER. CATHETER NOTED TO BE PARTIALLY SHEARED.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. INVALID DATA - REGARDING 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.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. INVALID DATA - WHETHER 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: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAUD-A KATH CATHETER GCB EPI-MED 155-1838

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other