BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLEGIANCE SILICONE ELASTOMER COATING

    MDR report key: 960159 · Received December 7, 2007

    Report

    Report Number
    9611710-2007-00001
    Event Type
    Malfunction
    Date Received
    December 7, 2007
    Date of Event
    October 19, 2007
    Report Date
    November 27, 2007
    Manufacturer
    UNOMEDICAL SDN BHD
    Product Code
    KOD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL COMPLAINT SAMPLE (USED PRODUCT) WAS NOT RETURNED FOR INVESTIGATION. ONLY 6 REPRESENTATIVE SAMPLES FROM THE SAME LOT OF MFG (485819R001) WERE RECEIVED FROM CARDINAL HEALTH ON THE 5TH NOV, 2007 FOR EVAL. NOTE: THE PRODUCTS INVOLVED IN THIS COMPLAINT WERE MANUFACTURED UNDER UNOMEDICAL LOT #: 485819R001 BUT RE-ASSEMBLED INTO PROCEDURE KITS BY CARDINAL HEALTH. NO DEFECT COULD BE DETECTED WITH THE RETURNED REP SAMPLES. PRODUCTS WERE FULLY FUNCTIONAL WHEN TESTED. FAILURE ENCOUNTERED BY THE USER COULD NOT BE DUPLICATED. HOWEVER, QA WILL CONTINUE TO TRACK AND TREND. SINCE THE ACTUAL COMPLAINT SAMPLE WAS NOT RETURNED, FURTHER INVESTIGATION IN DETERMINING AND CONFIRMING THE ROOT CAUSE OF PRODUCT FAILURE COULD NOT BE CARRIED OUT. SHOULD THE DEVICE BE RECEIVED AT THE LATER STAGE, QA WILL RE-OPEN THIS FILE FOR INVESTIGATION AND WILL FILE AN ADDENDUM TO THIS REPORT IF REQUIRED

    Description of Event or Problem · 1

    OPEN HEART SURGERY IN 2007. ATTEMPTED CATHETER REMOVAL FOUR DAYS LATER. CATHETER WOULDN'T DEFLATE. END OF CATHETER WAS CUT & STILL BALLOON DIDN'T DEFLATE. TRIED TO DEFLATE W/NEEDLE SUPRAPUBICALLY BUT WITH NO SUCCESS. PT PUT UNDER GENERAL ANESTHETIC & CATHETER REMOVED DURING CYSTO PROCEDURE. NOTE: "USER" NOTIFY CARDINAL HEALTH ON THE COMPLAINT IN 2007. CARDINAL HEALTH FORWARDED THE COMPLAINT TO UNOMEDICAL INC. USA IN 2007 AND UNOMEDICAL SDN. BHD RECEIVED AND ACKNOWLEDGED THE COMPLAINT IN 2007.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLEGIANCE SILICONE ELASTOMER COATING SILICONE ELASTOMER COATED CATHETER KOD UNOMEDICAL SDN BHD PS514 485819R001

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention