BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD MICRO-FINE¿ INSULIN PEN NEEDLE

    MDR report key: 7456175 · Received April 24, 2018

    Report

    Report Number
    9616656-2018-00094
    Event Type
    Injury
    Date Received
    April 24, 2018
    Date of Event
    April 10, 2018
    Report Date
    May 14, 2018
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    K051899
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: ONE FRAGMENT OF CANNULA WAS RETURNED FROM LOT. NO. 6173511, CAT. NO. (B)(4). AS NO HUB, COVER OR SHIELD WERE RETURNED NO FURTHER INVESTIGATION CAN BE CARRIED OUT. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCE'S WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. AS NO HUB, COVER OR SHIELD WERE RETURNED FOR INVESTIGATION IT CANNOT BE DETERMINED IF THIS WAS MANUFACTURING RELATED. BASED ON AN EVALUATION OF SEVERITY AND OCCURRENCE IT WAS DETERMINED THAT NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). 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 MICRO-FINE¿ INSULIN PEN NEEDLE BROKE OFF INTO THE PENIS DURING USE. THE CLIENT STATES HE THINKS THE NEEDLE MAY HAVE BEEN BROKEN PRIOR TO USE. THE NEEDLE WAS SURGICALLY REMOVED. NO OTHER ACTIONS TAKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298551 BD MICRO-FINE¿ INSULIN PEN NEEDLE PEN NEEDLE FMI BECTON DICKINSON AND CO. 6173511

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention