BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLEGIENCE SILICONE COATING

    MDR report key: 1429674 · Received July 5, 2009

    Report

    Report Number
    9611710-2009-00001
    Event Type
    Malfunction
    Date Received
    July 5, 2009
    Date of Event
    March 20, 2009
    Report Date
    May 6, 2009
    Manufacturer
    UNOMEDICAL SDN BHD
    Product Code
    KOD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UNOMEDICAL SDN. BHD.,(B)(4) RECEIVED THE EFFECTED SAMPLE ON THE 4TH MAY 2009. PRODUCT WAS CLOSELY EXAMINED. BALLOON HAD BURST UPON RECEIPT AND CATHETER SHAFT ABOVE THE BALLOON WAS CONTAMINATED WITH ENCRUSTATION OF SALT DEPOSIT. APART FROM THE BALLOON BEING BURST UPON RECEIPT, NO...DEFECT COULD BE SEEN ALONG THE ENTIRE INFLATION CHANNEL THAT COULD POSSIBLY HAVE RESULTED IN NON DEFLATION WAS DETECTED WHEN EXAMINED WITH DETAIL AS MENTIONED BELOW. AIR BUBBLES COULD BE SEEN ESCAPING AWAY FROM THE BALLOON SECTION WHEN THE CATHETER WAS DIPPED INTO A BEAKER OF WATER AND AIR WAS INTRODUCED VIA A SYRINGE INSERTED INTO THE VALVE WHICH INDICATES THAT THE INFLATION LUMEN WAS FREE FROM OBSTRUCTION AND THE VALVE WAS FULLY FUNCTIONAL. THE SLEEVE AND VALVE WAS REMOVED. NO RESTRICTION WAS ENCOUNTERED WHEN THE INFLATION LUMEN WAS GRADUALLY INSERTED WITH A FINE NYLON WIRE. THE "Y" SITE (INFLATION FUNNEL JUNCTION) WHEN CUT OPENED AND EXAMINED WAS FREE FROM OBSTRUCTION OR DEFORMITY. THE INFLATION ENTIRE INFLATION LUMEN WHEN CUT OPENED AND EXAMINED WAS FREE FROM OBSTRUCTION OR DEFORMITY. THE INFLATION HOLE WAS OF NORMAL SHAPE, SIZE AND FREE FROM OBSTRUCTION OR COLLAPSE. SINCE THE BALLOON HAD BURST UPON RECEIPT, FURTHER INVESTIGATION IN DETERMINING THE ROOT CAUSE OF PRODUCT FAILURE OR COMPLICATION ENCOUNTERED BY THE USER COULD NOT BE CARRIED OUT. COMPLAINT COULD NOT BE CONFIRMED AS PER RETURNED SAMPLE EVAL. COMPLICATION ENCOUNTERED BY THE USER COULD PROBABLY BEEN DUE TO THE IMPROPER SYRINGE INSERTION TECHNIQUE APPLIED DURING DEFLATION WHERE THE SYRINGE WAS NOT ADEQUATELY INSERTED INTO THE VALVE ORIFICE, THUS RESTRICT/PREVENT THE DEFLATION PROCESS.

    Description of Event or Problem · 1

    CUSTOMER STATES, THE BALLOON ON THE CATHETER WOULD NOT DEFLATE. INJURY WAS BEING REPORTED. HOWEVER, THE TYPE OF INJURY SUSTAINED BY THE PT UPON RECEIPT OF THE COMPLAINT WAS LEFT UNK. NOTE: (B)(4) FORWARDED THE COMPLAINT TO UNOMEDICAL INC., USA ON THE 7TH APRIL 2009. HOWEVER, UNOMEDICAL SDN. BHD, (B)(4) (THE MANUFACTURER) ONLY RECEIVED THE COMPLAINT NOTIFICATION FROM UNOMEDICAL INC, USA ON THE 28TH APRIL 2009. THE SAMPLE INVOLVED IN THE COMPLAINT WAS RECEIVED BY UNOMEDICAL SDN BHD ON THE 4TH MAY 2009. (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLEGIENCE SILICONE COATING SILICONIZED FOLEY CATHETER KOD UNOMEDICAL SDN BHD PE 518 491022R001

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR Other