BEUDAMED
    FDA Adverse Event Injury Summary report: N

    32 G X 4 MM BD ULTRA FINE¿ INSULIN PEN NEEDLE

    MDR report key: 5217148 · Received November 11, 2015

    Report

    Report Number
    9616656-2015-00018
    Event Type
    Injury
    Date Received
    November 11, 2015
    Date of Event
    October 16, 2015
    Report Date
    August 17, 2016
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    K131358
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    RELEVANT TESTS/LABORATORY DATA: THE PATIENT HAD HER INITIAL ABDOMINAL X-RAY ON (B)(6) 2015. DEVICE EVALUATION: RESULT - THE CUSTOMER RETURNED (10) SEALED 4MM, 32G PEN NEEDLES FROM LOT # 5092488. THE CUSTOMER STATES THAT WHEN THE PEN WAS REMOVED FROM THE SITE AFTER THE INJECTION, THE NEEDLE WAS GONE. ALL RETURNED PEN NEEDLES WERE EXAMINED AND NO BENT OR BROKEN CANNULA WAS OBSERVED ON ANY OF THE RETURNED SAMPLES. CONCLUSION - BASED ON THE SAMPLES RECEIVED, BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    RESULTS - A SAMPLE WAS NOT RETURNED FOR EVALUATION. CONCLUSION - WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: THIS DEVICE DOES NOT HAVE AN EXPIRATION DATE. EVALUATION: A DEVICE FROM THE SAME LOT IS AVAILABLE FOR EVALUATION BUT HAS NOT BEEN RECEIVED BY THE MANUFACTURER. A SUPPLEMENTAL REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO ABNORMALITIES DURING THE MANUFACTURE OF THE REPORTED LOT NUMBER 5092488.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BD ULTRA FINE INSULIN PEN NEEDLE BROKE OFF IN THE PATIENT'S STOMACH WHILE SHE WAS SELF INJECTING. SHE INFORMED HER MOTHER THAT IT BURNED AND WHEN SHE REMOVED THE PEN NEEDLE FROM THE SITE, THE NEEDLE WAS GONE. AN X-RAY CONFIRMED THE NEEDLE WAS RETAINED IN THE PATIENT'S STOMACH AND ANTIBIOTICS WERE GIVEN. PATIENT RETURNED ON (B)(6) 2015 FOR ADDITIONAL X-RAYS AND IT WAS DETERMINED SHE SHOULD STOP ANTIBIOTICS AND SEE IF THE NEEDLE WOULD WORK ITS WAY TO THE SURFACE ON ITS OWN. THE PATIENT DOES NOT REUSE PEN NEEDLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748438 32 G X 4 MM BD ULTRA FINE¿ INSULIN PEN NEEDLE INSULIN PEN NEEDLE FMI BECTON DICKINSON AND CO. 5092488

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Required Intervention