BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN PEN NEEDLE

    MDR report key: 7554192 · Received May 30, 2018

    Report

    Report Number
    9616656-2018-00111
    Event Type
    Malfunction
    Date Received
    May 30, 2018
    Date of Event
    May 3, 2018
    Report Date
    May 31, 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: ONE OPEN 31G X 5MM PEN NEEDLE SAMPLE WAS RETURNED FROM LOT. NO. 7052715, CAT. NO. 325104. VISUAL EXAMINATION WAS CARRIED OUT ON THE RETURNED SAMPLE AND IT WAS OBSERVED THAT THE PATIENT END OF THE CANNULA WAS BROKEN, NO SHIELD WAS RETURNED AND AN INDENTATION MARK WAS OBSERVED ON THE HUB. INVESTIGATION CONCLUSION: VISUAL EXAMINATION WAS CARRIED OUT ON THE RETURNED SAMPLE AND IT WAS OBSERVED THAT THE PATIENT END OF THE CANNULA WAS BROKEN, NO SHIELD WAS RETURNED AND AN INDENTATION MARK WAS OBSERVED ON THE HUB. 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 DESCRIPTION: ROOT CAUSE WAS INCORRECT LOADING OF THE SHIELD TO THE HUB AT THE SHIELDING STATION. CAPA (B)(4) WAS OPENED TO ADDRESS THIS ISSUE.

    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 A BD INSULIN PEN NEEDLE BROKE DURING USE. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394529 BD INSULIN PEN NEEDLE INSULIN PEN NEEDLE FMI BECTON DICKINSON AND CO. 7052715

    Patients

    Seq Age Sex Outcome Treatment
    1 Other