BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    100%SILICONE 2WAY PED 3 CC

    MDR report key: 4913107 · Received July 14, 2015

    Report

    Report Number
    8040412-2015-00158
    Event Type
    Malfunction
    Date Received
    July 14, 2015
    Date of Event
    May 13, 2015
    Report Date
    June 17, 2015
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FGH
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE LOT NUMBER WAS NOT PROVIDED; THEREFORE A DHR REVIEW COULD NOT BE CONDUCTED. VISUAL EXAMINATION WAS CONDUCTED ON THE RETURNED SAMPLE AND IT WAS OBSERVED THAT THE CATHETER WAS BROKEN INTO TWO PARTS; ONE ON SHAFT AND THE FUNNEL. THE RETURNED SAMPLE WAS REALIGNED AND MEASURED ON THE LENGTH OF IT USING A CALIBRATED RULER. IT WAS OBSERVED THAT THE OVERALL LENGTH MET THE SPECIFICATION OF THIS PRODUCT. THEN, BOTH THE CATHETER SHAFT AND FUNNEL WERE EXAMINED USING THE DINO-LITE TO ANALYZE THE DAMAGED AREA. BASED ON THE OBSERVATION THE TORN EDGES WERE JAGGED WHERE MORE MATERIAL WAS SEEN ON ONE SIDE OF THE CATHETER. VISUAL EXAMINATION ON THE OTHER AREAS OF THE CATHETER SHAFT DID NOT REVEAL ANY SIGN OF ABRASION MARK OR SCRATCH. THERE IS NO TRACE OF NICK OR SCRATCHES ON THE EMBEDDED SHAFT. BASED ON THE INVESTIGATION CONDUCTED, THE CATHETER WAS FOUND TO BE BROKEN. NO OTHER RELATED ISSUE WITHIN THE MANUFACTURING PROCESSES THAT COULD LEAD TO DEFECTIVE PRODUCT. THEREFORE THIS COMPLAINT COULD NOT BE CONFIRMED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE SAMPLE HAS NOT BEEN RETURNED FOR INVESTIGATION AT THE TIME OF THIS REPORT. THE MANUFACTURER WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 1

    ALLEGED EVENT: THE CATHETER WAS INSERTED PREOPERATIVELY AND WAS LATER FOUND SEVERED OR BROKEN AT THE Y JUNCTION. THE PATIENT'S CONDITION WAS REPORTED AS FINE.

    Description of Event or Problem · 1

    ALLEGED EVENT: THE CATHETER WAS INSERTED PREOPERATIVELY AND WAS LATER FOUND SEVERED OR BROKEN AT THE Y JUNCTION. THE PATIENT'S CONDITION WAS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457320 100%SILICONE 2WAY PED 3 CC FOLEY CATHETER FGH TELEFLEX MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1