BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UMBILICAL CLAMP

    MDR report key: 127287 · Received October 16, 1997

    Report

    Report Number
    1648571-1997-00001
    Event Type
    Malfunction
    Date Received
    October 16, 1997
    Report Date
    October 16, 1997
    Manufacturer
    QFC PLASTICS
    Product Code
    HFW
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    10, H.3 AFTER EXAMINING THE RETURNED DEVICE, IT HAS BEEN DETERMINED THAT BREAKAGE DID NOT OCCUR. IT APPEARS THAT THE DEVICE SLIPED OFF THE UMBILICAL CORD, ACCORDING TO UF REPORT. SLIPPAGE TESTS WERE CONDUCTED ON PARTS IN STOCK AND IT WAS FOUND TO TAKE CONSIDERABLE FORCE TO CAUSE SLIPPAGE BY PULLING. ALSO, 100 PSI AIR PRESSURE WAS USED IN AN EFFORT TO CAUSE SLIPPAGE AND THE PARTS DID NOT SLIP ON A VINYL TUBE COATED WITH PETROLEUM JELLY. (NOTE: TESTING WAS NOT DONE ON THE RETURNED DEVICE, BECAUSE IT WAS IN A CLOSED POSITION. OPENING THE DEVICE AFTER IT HAS BEEN CLOSED DESTROYS THE INTEGRITY OF THE LOCKING MECHANISM, RENDERING ANY SLIPPAGE TESTING ON THE RETURNED DEVICE INVALID.) UF INFO AND DEVICE WAS NOT REC'D UNTIL AFTER THE INITIAL 30 DAY PERIOD WAS PASSED. BOTH WERE HELD AT THE DIST UNTIL AFTER THAT TIME PERIOD. THIS REPORT SUPPLIES ADD'L INFO AND OUR ACTION TAKEN BASED ON THOSE REPORTS AND SAMPLE. H.7. MODIFICATION MADE IN PRODUCTION TOOLING TO INCREASE GRIP STRENGTH. PARTS MADE FROM MODIFIED TOOLING TO BE TESTED PRIOR TO MARKETING. ALL STOCK IN QFC'S CURRENT INVENTORY REJECTED AND SENT TO SCRAP. D.9. DEVICE RETURNED TO DIST BY UF, NOT MFR. THE DEVICE WAS NOT REC'D BY THE MFR UNTIL 10/27/97. HELD AT DIST'S FACILITY UNTIL THAT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UMBILICAL CLAMP UMBILICAL CLAMP HFW QFC PLASTICS QFC-650 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 *