BEUDAMED
    FDA Adverse Event Other Summary report: N

    JMS SYCLOC A.V. FISTULA NEEDLE SET

    MDR report key: 973448 · Received January 2, 2008

    Report

    Report Number
    3002807350-2007-00007
    Event Type
    Other
    Date Received
    January 2, 2008
    Date of Event
    November 13, 2007
    Report Date
    November 17, 2007
    Manufacturer
    JMS SINGAPORE PTE. LTD.
    Product Code
    FIE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AVF JOINT DETACHED FROM TUBE DURING DISCONNECTION OF AVF NEEDLE FROM FMC BLOODLINE AT THE END OF DIALYSIS PROCESS. END-USER DID NOT SEE ANY AIR POCKET AT BONDING AREA BEFORE USAGE. NO AIR EMBOLISM DURING TREATMENT. USUALLY, END-USER HOLDS AVF FEMALE CONNECTOR/JOINT AND TWIST THE PT MALE CONNECTOR FOR CONNECTION AND DISCONNECTION. REVIEW OF PRESERVED SAMPLES: PERFORMED VISUAL INSPECTION ON APPEARANCE OF PRESERVED SAMPLES (N=5EA). NO AIR POCKET, WHITE PATCHES, INSUFFICIENT BONDING OR POOR INSERTION WAS OBSERVED. PERFORMED JOINT TO TUBE PULL STRENGTH TEST ON PRESERVED SAMPLES (N=2EA). AVF JOINTS TO TUBE PULL STRENGTH WERE 8.8 KGF & 9.4 KGF. (JMSS QC SPECIFICATION JOINT + TUBE PULL TEST SPECIFICATION: >6 KGF.) REVIEW OF DEVICE HISTORY RECORDS (DHR): THE RECORDS WERE CHECKED AND NO DISCREPANCY WAS FOUND. NO PROCESS DEVIATION AND REWORK WAS ASSOCIATED TO THIS PRODUCT LOT. POSSIBLE ROOT CAUSE: SUCH COMPLAINT REPORTED CASE (AVF JOINT DETACHED FROM TUBE) MIGHT RELATE TO INSUFFICIENT COATING OF ADHESIVE ONTO TUBE-AVF JOINT BONDING AREA. BASED ON THE PRODUCTION TRACEABILITY, ALL THE TUBE-AVF JOINTS WERE BONDED BY AUTO-BONDING PROCESS ON HB MACHINE #4. MISALIGNMENT OF ADHESIVE COATING PIN MIGHT LEAD TO UNEVEN COATING OF ADHESIVE ONTO COATING CHUCK, AS A RESULT, INSUFFICIENT COATING MIGHT OCCUR AND CAUSING POOR INSERTION OF AVF JOINT TO TUBE. PRODUCTION INSPECTOR MIGHT HAVE OVERLOOKED THE DEFECT DURING 100% INSPECTION. CORRECTIVE ACTIONS: BY THE END OF DEC '07, PRODUCTION WILL CONVERT THE AUTO-BONDING PROCESS ON HB MACHINE #4 TO MANUAL BONDING PROCESS WHICH IS USING VALIDATED COATING JIG. MANUAL COATING IS MORE EFFICIENT IN TERMS OF COATING CONSISTENCY AND COATING LENGTH. ON 26-NOV-07, BRIEFED ALL RELATED OPERATORS AND INSPECTORS TO INCREASE THEIR AWARENESS FOR THE DEFECT DURING ASSEMBLY PROCESS AND INSPECTION.

    Description of Event or Problem · 1

    LUER LOCK CAME OFF AT THE END OF TREATMENT; NO BLOOD LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JMS SYCLOC A.V. FISTULA NEEDLE SET A.V. FISTULA NEEDLE FIE JMS SINGAPORE PTE. LTD. 824-1501 070713531

    Patients

    Seq Age Sex Outcome Treatment
    1 Other