BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NEEDLE 32X4 ASIA XTW

    MDR report key: 10617561 · Received October 1, 2020

    Report

    Report Number
    2243072-2020-01549
    Event Type
    Malfunction
    Date Received
    October 1, 2020
    Date of Event
    September 8, 2020
    Report Date
    October 6, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: CUSTOMER RETURNED (99) SEALED 4MM, 32G PEN NEEDLES WITH THE SHELF CARTON FROM LOT # 5063366. CUSTOMER STATES THAT THERE IS DIFFICULTY ATTACHING THE NEEDLES AND THEY WERE BENDING. THIRTY OUT OF 99 RETURNED PEN NEEDLES WERE TESTED FOR POINT GEOMETRY, LUBE, AND CANNULA OD (SPECS: OUTER DIAMETER FOR 32G: 0.0090¿-0.0095¿). ALL OBSERVATIONS FALL WITHIN SPECIFICATIONS. ALSO, THESE SAMPLES WERE TESTED AND ALL WERE ABLE TO SECURELY ATTACH AND EASILY DETACH FROM A PEN. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PEN NEEDLE 32X4 ASIA XTW WERE DIFFICULT TO ATTACH. THIS OCCURRED ON 20 OCCASIONS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DIFFICULTY IN ATTACHING THE NEEDLES AND THEY ARE BENDING. PATIENT HAS DIFFICULTY ATTACHING THE NEEDLES AND THEY ARE BENDING. HE PREFERRED THE PRO AND HAS SWITCHED TO NN.

    Additional Manufacturer Narrative · 1

    UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS BD DEVICE MAY HAVE BEEN MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED, AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PEN NEEDLE 32X4 ASIA XTW WERE DIFFICULT TO ATTACH. THIS OCCURRED ON 20 OCCASIONS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DIFFICULTY IN ATTACHING THE NEEDLES AND THEY ARE BENDING. PATIENT HAS DIFFICULTY ATTACHING THE NEEDLES, AND THEY ARE BENDING. HE PREFERRED THE PRO, AND HAS SWITCHED TO NN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1076412 PEN NEEDLE 32X4 ASIA XTW PEN NEEDLE FMI BECTON DICKINSON 5085265

    Patients

    Seq Age Sex Outcome Treatment
    1 Other