BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ BLUNT FILL NEEDLE

    MDR report key: 9123723 · Received September 26, 2019

    Report

    Report Number
    1911916-2019-01007
    Event Type
    Malfunction
    Date Received
    September 26, 2019
    Date of Event
    September 11, 2019
    Report Date
    October 28, 2019
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    GAA
    UDI-DI
    30382903051800
    PMA / PMN Number
    SEE H.10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: ONE (1) SAMPLE WAS PROVIDED BY THE CUSTOMER FOR INVESTIGATION. THE NEEDLE ASSEMBLY WAS RETURNED ATTACHED TO A SYRINGE. THERE IS BLUE LIQUID IN THE NEEDLE SHIELD, ON THE NEEDLE HUB ASSEMBLY, AND IN THE BAGGIE THAT THE SAMPLE WAS RETURNED IN. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED ON THE BATCH ASSOCIATED WITH THIS INVESTIGATION. THE DHR REVIEWS DID NOT REVEAL ANY DEFECTS OR ISSUES REPORTED AND NO QUALITY NOTIFICATIONS WERE ISSUED. BD ACKNOWLEDGES THAT THE RETURNED SAMPLE HAS BLUE LIQUID IN THE NEEDLE SHIELD, ON THE NEEDLE HUB ASSEMBLY, AND IN THE BAGGIE THAT THE SAMPLE WAS RETURNED IN. HOWEVER, AS THIS PRODUCT HAS SEEN ADDITIONAL HANDLING WHERE THE BLUE LIQUID CAME FROM CANNOT BE DETERMINED; THEREFORE, A ROOT CAUSE CANNOT BE DETERMINED. BD ACKNOWLEDGES THAT THE RETURNED SAMPLE HAS BLUE LIQUID IN THE NEEDLE SHIELD, ON THE NEEDLE HUB ASSEMBLY, AND IN THE BAGGIE THAT THE SAMPLE WAS RETURNED IN. HOWEVER, AS THIS PRODUCT HAS SEEN ADDITIONAL HANDLING WHERE THE BLUE LIQUID CAME FROM CANNOT BE DETERMINED; THEREFORE, A ROOT CAUSE CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD¿ BLUNT FILL NEEDLE HAD FOREIGN MATTER INSIDE. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BLUE FLUID FOUND INSIDE NEEDLE.

    Additional Manufacturer Narrative · 1

    PMA/510(K)#: CLASS I EXEMPT. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD¿ BLUNT FILL NEEDLE HAD FOREIGN MATTER INSIDE. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BLUE FLUID FOUND INSIDE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    920604 BD¿ BLUNT FILL NEEDLE MANUAL SURGICAL INSTRUMENT FOR GENERAL USE GAA BD MEDICAL (BD WEST) MEDICAL SURGICAL 8250833 30382903051800

    Patients

    Seq Age Sex Outcome Treatment
    1 Other