BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD MICRO-FINE¿ PEN NEEDLE

    MDR report key: 8206191 · Received December 31, 2018

    Report

    Report Number
    9616656-2018-00334
    Event Type
    Injury
    Date Received
    December 31, 2018
    Date of Event
    December 3, 2018
    Report Date
    January 23, 2019
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: FORTY THREE SEALED 31G X 5MM PEN NEEDLE SAMPLES AND FOUR PHOTOS WERE RETURNED FROM LOT. NO. 8003822, CAT. NO. 320595. VISUAL EXAMINATION WAS CARRIED OUT ON ALL FORTY THREE SAMPLES AND NO ISSUES WERE OBSERVED. VISUAL EXAMINATION OF THE RETURNED PHOTOS WAS ALSO CARRIED OUT AND A BROKEN PATIENT END OF CANNULA WAS 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. NO ISSUES WERE OBSERVED WITH THE RETURNED SAMPLES AND BASED ON THE PHOTOS RETURNED THIS CANNOT BE CONFIRMED TO BE MANUFACTURING RELATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD MICRO-FINE¿ PEN NEEDLE DETACHED FROM THE DEVICE AND REMAINED "IN THE PATIENT'S BUTTOCK". THE PATIENT WAS REPORTED TO HAVE VISITED THE HOSPITAL EMERGENCY ROOM, WHERE A "TEST PERFORMED RX (PELVIS AND SACROILIAC JOINT)" WAS DONE. THE TEST YIELDED "THREADY FOREIGN MATTER IN THE SOFT TISSUES OF THE RIGHT BUTTOCK COMPATIBLE WITH THE PEN NEEDLE REPORTED BY THE PATIENT". A PRE-SURGERY EXAMINATION WAS ALSO COMPLETED, BUT THE "FAMILY DECIDED NOT TO PROCEED.. CONSIDERING THE INVASIVENESS OF THE SURGERY".

    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 THE BD MICRO-FINE¿ PEN NEEDLE DETACHED FROM THE DEVICE AND REMAINED "IN THE PATIENT'S BUTTOCK". THE PATIENT WAS REPORTED TO HAVE VISITED THE HOSPITAL EMERGENCY ROOM, WHERE A "TEST PERFORMED RX (PELVIS AND SACROILIAC JOINT)" WAS DONE. THE TEST YIELDED "THREADY FOREIGN MATTER IN THE SOFT TISSUES OF THE RIGHT BUTTOCK COMPATIBLE WITH THE PEN NEEDLE REPORTED BY THE PATIENT". A PRE-SURGERY EXAMINATION WAS ALSO COMPLETED, BUT THE "FAMILY DECIDED NOT TO PROCEED. CONSIDERING THE INVASIVENESS OF THE SURGERY".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1045376 BD MICRO-FINE¿ PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 8003822

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Required Intervention