BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ INSULIN PEN NEEDLE

    MDR report key: 7186749 · Received January 12, 2018

    Report

    Report Number
    9616656-2017-00181
    Event Type
    Malfunction
    Date Received
    January 12, 2018
    Date of Event
    December 4, 2017
    Report Date
    February 26, 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 · 1

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

    Additional Manufacturer Narrative · 1

    ONE OPEN 31G X 5MM PEN NEEDLE SAMPLE AND A FRAGMENT OF BROKEN CANNULA WERE RETURNED FROM LOT NO. 7052715, CAT. NO. 325104. NO SHIELD WAS RETURNED. MAGNIFIED INSPECTION WAS CARRIED OUT AND IT WAS OBSERVED THAT THE PATIENT END OF CANNULA WAS BROKEN AND AN INDENTATION MARK WAS PRESENT ON THE HUB POST. 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 OF THIS ISSUE WAS INCORRECT LOADING OF THE SHIELD TO THE HUB AT THE SHIELDING STATION. CAPA (B)(4) WAS OPENED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INSULIN INJECTION A BD¿ INSULIN PEN NEEDLE BROKE OFF AND REMAINED IN THE PATIENT¿S SKIN. THE PATIENT WAS ABLE TO REMOVE THE NEEDLE WITH TWEEZERS AND MEDICAL ATTENTION WAS SOUGHT. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31262 BD¿ INSULIN PEN NEEDLE INSULIN PEN NEEDLE FMI BECTON DICKINSON AND CO. 7052715

    Patients

    Seq Age Sex Outcome Treatment
    1 Other