BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BLUNT FILL NEEDLE WITH FILTER

    MDR report key: 11283889 · Received February 5, 2021

    Report

    Report Number
    1911916-2021-00092
    Event Type
    Malfunction
    Date Received
    February 5, 2021
    Date of Event
    January 13, 2021
    Report Date
    January 27, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    GAA
    UDI-DI
    30382903052111
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(4). INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305211 AND LOT NUMBER 8250854. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED DEFECT. TO AID IN THE INVESTIGATION, ONE PHOTO WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTO SHOWS A NEEDLE ASSEMBLY WITH NO PACKAGING BLISTER AND THE PLASTIC SHIELD HAS BEEN REMOVED. THE NEEDLE HAS WHITE EPOXY DRIP OVER AT THE MIDDLE OF THE NEEDLE. IT COULD BE POSSIBLE FOR THIS DEFECT TO OCCUR DURING THE ASSEMBLY PROCESS. THE PLASTIC HUB IS PLACED UNDER THE CANNULATOR, THEN THE NEEDLE IS POSITIONED AND ASSEMBLED TO THE PLASTIC HUB ADDING THE WHITE EPOXY TO FIX IT. IT MAY HAVE HAPPENED THAT JAM OCCURRED AT THE CANNULATOR INDUCING THE WHITE EPOXY DRIP OVER ON THE NEEDLE. BASED ON THE INVESTIGATION WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "> 10MM IN LENGTH" OF GLUE WAS FOUND ON THE BD¿ BLUNT FILL NEEDLE WITH FILTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE RECEIVED A COMPLAINT ABOUT THE ABOVE FILTER NEEDLE FROM A (B)(6) CUSTOMER. THE REASON FOR THE COMPLAINT WERE LARGE RESIDUES OF GLUE ON THE FILTER NEEDLE. THE RESIDUE IS IN THE MIDDLE OF THE NEEDLE AND IS > 10MM IN LENGTH"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182203 BD BLUNT FILL NEEDLE WITH FILTER MANUAL SURGICAL INSTRUMENT FOR GENERAL USE GAA BD MEDICAL (BD WEST) MEDICAL SURGICAL 305211 8250854 30382903052111

    Patients

    Seq Age Sex Outcome Treatment
    1