BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ INSULIN PEN NEEDLE

    MDR report key: 7949912 · Received October 9, 2018

    Report

    Report Number
    9616656-2018-00223
    Event Type
    Malfunction
    Date Received
    October 9, 2018
    Date of Event
    September 12, 2018
    Report Date
    October 16, 2018
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    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 IT WAS OBSERVED THAT ONE SAMPLE HAD A CANNULA THROUGH SHIELD. NO ISSUES WERE OBSERVED WITH THE SECOND SAMPLE. 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 · 0

    IT WAS REPORTED THAT THE BD¿ INSULIN PEN NEEDLE WENT THROUGH THE SHIELD. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    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 THE BD¿ INSULIN PEN NEEDLE WENT THROUGH THE SHIELD. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787034 BD¿ INSULIN PEN NEEDLE PEN NEEDLE FMI BECTON DICKINSON AND CO. 7052715

    Patients

    Seq Age Sex Outcome Treatment
    1 Other