BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NEEDLE 32X4 ASIA XTW

    MDR report key: 10817093 · Received November 10, 2020

    Report

    Report Number
    9616656-2020-01114
    Event Type
    Malfunction
    Date Received
    November 10, 2020
    Date of Event
    October 15, 2020
    Report Date
    December 11, 2020
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ONE PHOTO OF TWO OPEN 32G X 4MM PEN NEEDLE SAMPLES WERE RETURNED FROM LOT. NO. 0022836, CAT. NO. 320477. VISUAL EXAMINATION OF THE RETURNED PHOTO WAS CARRIED OUT AND A BROKEN NON PATIENT END OF CANNULA WAS OBSERVED ON ONE SAMPLE. 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. AS THE SAMPLES IN THE RETURNED PHOTO WERE OPEN IT IS NOT POSSIBLE TO CONFIRM THIS DEFECT TO BE MANUFACTURING RELATED. SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PEN NEEDLE 32X4 ASIA XTW WAS DAMAGED BEFORE USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "SUBMIT ON BEHALF (DC CLINICAL SPECIALIST) - COMPLAINANT IS A DIABETES NURSE EDUCATOR AND WAS GOING TO DEMONSTRATE THE INSULIN INJECTION PEN USAGE TO PATIENT - A NEW BD ULTRAFINE 4MM NEEDLE WAS USED AND SHE REALIZED THE NEEDLE WAS HAVING MISSING/BROKEN INNER NEEDLE CANNULA."

    Additional Manufacturer Narrative · 1

    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 A PEN NEEDLE 32X4 ASIA XTW WAS DAMAGED BEFORE USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER, "SUBMIT ON BEHALF (DC CLINICAL SPECIALIST) COMPLAINANT IS A DIABETES NURSE EDUCATOR, AND WAS GOING TO DEMONSTRATE THE INSULIN INJECTION PEN USAGE TO PATIENT." A NEW BD ULTRAFINE 4MM NEEDLE WAS USED AND SHE REALIZED THE NEEDLE WAS HAVING MISSING/BROKEN INNER NEEDLE CANNULA."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1284641 PEN NEEDLE 32X4 ASIA XTW HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 0022836

    Patients

    Seq Age Sex Outcome Treatment
    1