BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA FINE¿ PEN NEEDLES

    MDR report key: 9662333 · Received February 3, 2020

    Report

    Report Number
    9616657-2020-00020
    Event Type
    Malfunction
    Date Received
    February 3, 2020
    Date of Event
    January 14, 2020
    Report Date
    February 21, 2020
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    10885403928659
    PMA / PMN Number
    K162516
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: CUSTOMER RETURNED (67) UNUSED/SEALED 32GX4MM BD PEN NEEDLES FROM LOT 8150783. CONSUMER REPORTED NEEDLE CLOG DURING PRIMING. 30 OUT OF THE 67 RETURNED PEN NEEDLES WERE EXAMINED, THEN TESTED FOR FLOW USING A TEST PEN INJECTOR: ALL 30 TESTED PEN NEEDLES WERE ABLE TO EXPEL PROPERLY. SINCE NO EVIDENCE OF MANUFACTURING DEFECT WAS OBSERVED THE ALLEGED ISSUE COULD NOT BE CONFIRMED. 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. BASED ON THE SAMPLES AND/OR PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: UNCONFIRMED: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD ULTRA FINE¿ PEN NEEDLES WERE CLOGGED DURING PRIMING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 320122 BATCH NO. 8150783 IT WAS REPORTED THAT NEEDLE CLOGGED DURING PRIMING. VERBATIM: CONSUMER REPORTED NEEDLE CLOG DURING PRIMING, DOES NOT RE-USE, SAMPLES WILL BE SUBMITTED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 ULTRA FINE¿ PEN NEEDLES WERE CLOGGED DURING PRIMING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 320122 BATCH NO. 8150783. IT WAS REPORTED THAT NEEDLE CLOGGED DURING PRIMING. VERBATIM: CONSUMER REPORTED NEEDLE CLOG DURING PRIMING, DOES NOT RE-USE, SAMPLES WILL BE SUBMITTED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126167 BD ULTRA FINE¿ PEN NEEDLES HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON, DICKINSON AND CO. 2865 8150783 10885403928659

    Patients

    Seq Age Sex Outcome Treatment
    1 Other