BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ INSULIN PEN NEEDLE

    MDR report key: 7234103 · Received February 1, 2018

    Report

    Report Number
    9616656-2018-00005
    Event Type
    Malfunction
    Date Received
    February 1, 2018
    Date of Event
    January 2, 2018
    Report Date
    May 23, 2018
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    K131358
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: TWO OPEN 31G X 5MM PEN NEEDLE SAMPLES WERE RETURNED FROM LOT NO. 7052715, CAT. NO. 325104. VISUAL EXAMINATION WAS CARRIED OUT ON THE RETURNED SAMPLES AND NO ISSUES WERE OBSERVED. A FULL SEAL WAS OBSERVED ON THE TEARDROP LABEL AND COVER. 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. INVESTIGATION CONCLUSION NO ISSUES WERE OBSERVED WITH THE RETURNED SAMPLES THEREFORE NO ROOT CAUSE CAN BE IDENTIFIED.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE USE, A BD¿ INSULIN PEN NEEDLE WAS FOUND WITH A BREACH IN STERILE INTEGRITY AS THE ¿NEEDLES ARRIVED PARTLY OPEN AND BENT.¿ THERE IS NO REPORT OR INJURY OR MEDICAL INTERVENTION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77468 BD¿ INSULIN PEN NEEDLE INSULIN PEN NEEDLE FMI BECTON DICKINSON AND CO. 7052715

    Patients

    Seq Age Sex Outcome Treatment
    1 Other