BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD INSULIN PEN NEEDLE 31G X 5MM

    MDR report key: 6116795 · Received November 21, 2016

    Report

    Report Number
    9616656-2016-00074
    Event Type
    Injury
    Date Received
    November 21, 2016
    Date of Event
    October 31, 2016
    Report Date
    December 14, 2016
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    K051899
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: RESULT - ONE OPEN PEN NEEDLE SAMPLE FROM THE REPORTED LOT 5036117, CATALOG 325104 WAS RETURNED FOR EVALUATION. A VISUAL EXAMINATION WAS CARRIED OUT AND IT WAS OBSERVED THAT THE IV END WAS BROKEN. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NONCONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT, CONCLUDING ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS AND QC SPECIFICATIONS. CONCLUSION - BD WAS ABLE TO CONFIRM THE CUSTOMER'S INDICATED FAILURE MODE. THE POTENTIAL CAUSE OF THIS ISSUES LIES AT THE SHIELDING STATION IN BD ASSEMBLY PROCESS. IF THE NEEDLE IS PRESENTED TO THE SHIELDER OBLIQUELY, THE DOWNWARD MOVEMENT OF THE EMPTY SHIELD RESULTS IN THE NEEDLE PENETRATING THE SHIELD. CAPA (B)(4) WAS RAISED FOR THE NEEDLE THROUGH SHIELD ISSUES AND IS CURRENTLY AT THE EFFECTIVENESS STAGE.

    Additional Manufacturer Narrative · 1

    THE DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY THE MANUFACTURER IS USED. (B)(4). IT IS UNKNOWN IF A SAMPLE IS AVAILABLE FOR EVALUATION. A SUPPLEMENTAL REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEEDLE FROM THE SUSPECT DEVICE BROKE OFF IN THE PATIENT'S SITE DURING USE. A SMALL SURGERY WAS PERFORMED AT THE HOSPITAL TO REMOVE THE BROKEN NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767867 BD INSULIN PEN NEEDLE 31G X 5MM INSULIN PEN NEEDLE FMI BECTON DICKINSON AND CO. 5036117

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention