BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    31 G X 5 MM BD ULTRA FINE¿ INSULIN PEN NEEDLE

    MDR report key: 6960193 · Received October 18, 2017

    Report

    Report Number
    9616656-2017-00120
    Event Type
    Malfunction
    Date Received
    October 18, 2017
    Date of Event
    September 28, 2017
    Report Date
    November 28, 2017
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    K131358
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: ONE OPEN 31G X 5MM PEN NEEDLE SAMPLE AND FOUR PHOTOS WERE RETURNED FROM LOT. NO. 4122221, CAT. NO. 320119. VISUAL EXAMINATION WAS CARRIED OUT ON THE RETURNED SAMPLE AND PHOTOS AND A BROKEN PATIENT END OF NEEDLE WAS OBSERVED. INDENTATION ON THE HUB WAS ALSO OBSERVED. 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. A REVIEW OF THE COMPLAINTS DATABASE WAS PERFORMED AND THERE HAVE BEEN NO TRENDS IDENTIFIED ON THIS LOT NUMBER. ROOT CAUSE OF THIS ISSUE WAS INCORRECT LOADING OF THE SHIELD TO THE HUB AT THE SHIELDING STATION. (B)(4) WAS OPENED TO ADDRESS THIS ISSUE.

    Additional Manufacturer Narrative · 1

    THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. LOT # 4122221 WAS PROVIDED BY CUSTOMER, HOWEVER IS NOT AN ACTUAL LOT FOR THIS PRODUCT. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEEDLE OF THE 31 G X 5 MM BD ULTRA FINE¿ INSULIN PEN NEEDLE BROKE OFF IN CONSUMERS STOMACH DURING INJECTION TWICE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739084 31 G X 5 MM BD ULTRA FINE¿ INSULIN PEN NEEDLE PEN NEEDLE FMI BECTON, DICKINSON AND CO. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other