BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ PEN NEEDLE

    MDR report key: 8286530 · Received January 29, 2019

    Report

    Report Number
    9616657-2019-00108
    Event Type
    Malfunction
    Date Received
    January 29, 2019
    Date of Event
    January 13, 2019
    Report Date
    February 12, 2019
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: ONE OPEN 32G X 4MM PEN NEEDLE SAMPLE WAS RETURNED FROM LOT. NO. 5231422, CAT. NO. 320177. VISUAL EXAMINATION WAS CARRIED OUT ON THE RETURNED SAMPLE AND A BROKEN NON PATIENT END OF CANNULA WAS OBSERVED. DUE TO THE CONDITION THE SAMPLE WAS RETURNED NO CLOG TEST COULD BE CARRIED OUT. 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. IT IS BD¿S EXPERIENCE THAT THE NON-PATIENT END BREAKAGE AND BENDING IS DIRECTLY ASSOCIATED WITH THE PLACING OF THE NEEDLE ONTO THE PEN DEVICE BY THE USER. IF THE NON-PATIENT END OF THE NEEDLE IS NOT PLACED CENTRALLY TO THE PEN DEVICE, THEN INSTEAD OF THE NON-PATIENT END OF THE NEEDLE PIERCING THE RUBBER SEPTUM OF THE VIAL, IT HITS HARD MATERIAL AND CAN BE BENT/BROKEN WHEN FITTED TO THE PEN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD¿ PEN NEEDLE WAS CLOGGED DURING PRIMING. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD¿ PEN NEEDLE WAS CLOGGED DURING PRIMING. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79206 BD¿ PEN NEEDLE PEN NEEDLE FMI BECTON, DICKINSON AND CO. 5231422

    Patients

    Seq Age Sex Outcome Treatment
    1 Other