BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD INSULIN PEN NEEDLE

    MDR report key: 7200881 · Received January 17, 2018

    Report

    Report Number
    9616656-2017-00197
    Event Type
    Injury
    Date Received
    January 17, 2018
    Date of Event
    December 26, 2017
    Report Date
    April 11, 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 · 1

    (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: BD RECEIVED 69 SEALED AND INTACT AND ONE OPEN 31G X 5MM PEN NEEDLE SAMPLES FROM LOT. NO. 7052715, CAT. NO. 325104. VISUAL EXAMINATION WAS CARRIED OUT ON THE OPENED SAMPLE AND A BROKEN PATIENT END OF NEEDLE WAS OBSERVED. INDENTATION ON THE HUB WAS ALSO OBSERVED. VISUAL EXAMINATION WAS ALSO CARRIED OUT ON 30 OF THE SEALED SAMPLES AND IT WAS OBSERVED THAT ONE SAMPLE HAD A CANNULA THROUGH SHIELD. A CLOG TEST WAS ALSO CARRIED OUT ON 30 SAMPLES AND NO ISSUES WERE 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. ROOT CAUSE OF THIS ISSUE WAS INCORRECT LOADING OF THE SHIELD TO THE HUB AT THE SHIELDING STATION. CAPA 131809 WAS OPENED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED AFTER USE OF THE BD INSULIN PEN NEEDLE THE PATIENT PRESENTED TO THE CLINIC ON FRIDAY, WITH COMPLAINTS THAT A PEN NEEDLE BROKEN OFF AND WAS STUCK IN HIS THIGH. THE NEEDLE COULD NOT BE FOUND BY X-RAY, SO THEY COULD NOT REMOVE IT SURGICALLY. PATIENT WENT HOME, BUT HAD TO OBSERVE THE SPOT WHERE THE NEEDLE BROKE OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46241 BD INSULIN PEN NEEDLE INSULING PEN NEEDLE FMI BECTON DICKINSON AND CO. 7052715

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention