BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA FINE¿ INSULIN PEN NEEDLE

    MDR report key: 9298362 · Received November 8, 2019

    Report

    Report Number
    9616657-2019-00363
    Event Type
    Malfunction
    Date Received
    November 8, 2019
    Date of Event
    October 24, 2019
    Report Date
    December 10, 2019
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903204786
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: CUSTOMER RETURNED (10) SEALED 4MM, 32G PEN NEEDLES IN THE SHELF CARTON FROM LOT # 8242669. CUSTOMER STATES THAT THERE IS DIFFICULTY INSERTING NEEDLE INTO SKIN (LOOKS BLUNT) CAUSING PAIN, BRUISING AND INSULIN LEAKAGE WHEN REMOVING THE NEEDLE. ALL 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, ALL SAMPLES WERE TESTED AND ALL SAMPLES WERE ABLE TO EXPEL PROPERLY WITH NO LEAKAGE OBSERVED ON ANY OF THE SAMPLES. 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 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 HAS BEEN REPORTED THAT THE BD ULTRA FINE¿ INSULIN PEN NEEDLE HAS BEEN FOUND EXPERIENCING LEAKAGE DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: DIFFICULTY INSERTING NEEDLE INTO SKIN (LOOKS BLUNT) CAUSING PAIN, BRUISE AND INSULIN LEAKAGE WHEN REMOVING THE NEEDLE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). 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 HAS BEEN REPORTED THAT THE BD ULTRA FINE¿ INSULIN PEN NEEDLE HAS BEEN FOUND EXPERIENCING LEAKAGE DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: DIFFICULTY INSERTING NEEDLE INTO SKIN (LOOKS BLUNT) CAUSING PAIN, BRUISE AND INSULIN LEAKAGE WHEN REMOVING THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1088824 BD ULTRA FINE¿ INSULIN PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON, DICKINSON AND CO. 8242669 00382903204786

    Patients

    Seq Age Sex Outcome Treatment
    1 Other