BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WINGED INFUSION SET, 20GA 3/4"

    MDR report key: 2971715 · Received January 30, 2013

    Report

    Report Number
    2245270-2013-00006
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    December 13, 2012
    Report Date
    January 30, 2013
    Manufacturer
    VYGON MANUFACTURING
    Product Code
    FMI
    PMA / PMN Number
    K873957
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE: THE CLINICIAN REPORTED FOUR OCCURRENCES OF THIS PRODUCT PROBLEM ON ONE PRODUCT INCIDENT REPORT. PLEASE REFERENCE THE MDRS LISTED BELOW FOR THE ADDITIONAL OCCURRENCES: MDR 2245270-2013-00003, 00004, 00005. WHILE THE CUSTOMER DID NOT RETURN THE MALFUNCTIONING DEVICES, THE CUSTOMER WAS ABLE TO RETURN FOUR UNOPENED DEVICES. VYGON PERFORMED A COMPLETE COMPLAINT INVESTIGATION USING THE UNOPENED SAMPLE AND A LOT HISTORY REVIEW. EXAMINATION OF THE UNOPENED DEVICES INDICATED THAT THE DEVICES FUNCTIONED AS INTENDED. VYGON PERFORMED A FUNCTIONAL TEST BY ATTACHING A WATER FILLED 60ML SYRINGE TO THE PROXIMAL END OF THE SETS AND PRESSURIZED THEM TO HELP DETERMINE THE ACTUAL LOCATION OF ANY LEAKAGE. NONE OF THE SETS LEAKED. WITHOUT HAVING THE ACTUAL SET TO EXAMINE AND AFTER CONDUCTING A THOROUGH INVESTIGATION INTO THIS CLAIM VYGON CANNOT CONFIRM A QUALITY PROBLEM WITH THIS LOT OF PRODUCT. ALL MANUFACTURING STEPS WERE PERFORMED AND ALL IN-PROCESS QUALITY CONTROL TESTING PASS THE INSPECTION ACCEPTANCE QUALITY LEVEL (AQL). ACCORDING TO VYGON'S RECORDS, (B)(4) PARTS WERE TESTED FOR PRESSURE AND OCCLUSION TESTING DURING MANUFACTURING ALL WITH PASSING RESULTS. ALTHOUGH VYGON CANNOT CONFIRM A QUALITY PROBLEM WITH THIS PRODUCT IT WILL CONTINUE TO BE VIGILANT FOR THIS TYPE OF COMPLAINT.

    Description of Event or Problem · 1

    NURSE PLACED HUBER NEEDLE IN PT'S PORT THEN ATTEMPTED TO FLUSH PORT WITH NORMAL SALINE. UPON PUSHING THE SALINE, IT WOULD SQUIRT BACKWARDS OUT OF TUBING AND ONTO THE PT. NURSE REMOVED THE SYRINGE FROM THE END OF TUBING AND UPON INSPECTION NOTICED THAT THE END OF TUBING WAS DEFECTIVE, EITHER CRACKED OR MIS-SHAPEN. THIS PRODUCT PROBLEM OCCURRED THREE MORE TIMES IN THE SAME WAY ON THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41998 WINGED INFUSION SET, 20GA 3/4" HUBER INFUSION SET FMI VYGON MANUFACTURING MSY-2034 1111045

    Patients

    Seq Age Sex Outcome Treatment
    1