BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIBLE TIP WITH SLIMLINE RETENTION

    MDR report key: 1051373 · Received May 16, 2008

    Report

    Report Number
    9610849-2008-00010
    Event Type
    Malfunction
    Date Received
    May 16, 2008
    Date of Event
    December 4, 2003
    Report Date
    December 4, 2003
    Manufacturer
    COVIDIEN
    Product Code
    FCE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE: THIS DEFECT IS AN OPERATIONAL ERROR DUE THAT THE GLUE IS APPLIED TO THE TIP AND ADAPTER MANUALLY. CONCLUSIONS: DEVICE HISTORY RECORD WAS REVIEWED FINDING NO DEFECTS DETECTED IN THE INSPECTION OF THIS LOT. TWENTY ONE SAMPLES WERE RECEIVED FROM LOT NUMBER 3202055 OF MODEL NUMBER 119042. ALL SAMPLES WERE EVALUATED UNDER PROCEDURE FOR TENSILE STRENGTH AND IN FACT, IN ONE OF THE SAMPLES, THE PLASTIC ADAPTER GETS LOOSE. THEREFORE THIS COMPLAINT WAS CONFIRMED. CORRECTIVE ACTIONS: A NOTIFICATION REPORT IS BEING ISSUED TO INFORM ALL PERSONNEL WITHIN THE ENEMA TIPS ASSEMBLY PROCESS ABOUT THIS PROBLEM. OUR PRODUCTION PROCESS IS BEING CHECKED PUTTING SPECIAL ATTENTION ON THIS ISSUE. WITH THE REFERENCE REPORTED, NOTIFICATION WAS PROVIDED TO APPROPRIATE MANUFACTURING AND QUALITY ASSURANCE PERSONNEL.

    Description of Event or Problem · 1

    CUSTOMER REPORTS ENEMA TIP SEPARATED FROM THE CLEAR PLASTIC ADAPTER THAT ATTACHES TO THE BAG AND ENTERED THE PATIENT'S BODY DURING A PROCEDURE. PATIENT WAS A MALE. COMPLAINANT INSPECTED OTHER TIPS IN THE BOX AND FOUND AT LEAST ONE OTHER WHERE THE TIP WERE NOT SECURELY FASTENED TO THE ADAPTER. IT SLIDES OUT AS IF THE ADAPTER WAS TOO SMALL OR THERE WAS NO GLUE ON IT (NOT SNUG). TWO CASES WILL BE RETURNED FOR INVESTIGATION. THE USED TIPS WERE DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXIBLE TIP WITH SLIMLINE RETENTION ENEMA TIP FCE COVIDIEN FLEXIBLE TIP 3202055

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR