BEUDAMED
    FDA Adverse Event Injury Summary report: N

    31 GX 8MM BD MICRO-FINE¿ INSULIN PEN NEEDLE

    MDR report key: 6183273 · Received December 16, 2016

    Report

    Report Number
    9616656-2016-00077
    Event Type
    Injury
    Date Received
    December 16, 2016
    Date of Event
    November 28, 2016
    Report Date
    December 15, 2016
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    K123300
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). RESULTS: A SAMPLE IS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED AS A LOT NUMBER WAS NOT PROVIDED FOR THIS INCIDENT. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 31G X 8MM BD MICRO-FINE¿ INSULIN PEN NEEDLE BROKE OFF IN A CONSUMER¿S ABDOMEN AFTER SHE HAD PROVIDED HERSELF AN INSULIN INJECTION. THERE WAS SOME SLIGHT REDNESS AND SWELLING AT THE INJECTION SITE AND SHE APPLIED AN ALUMINIUM ACETOTARTRATE SOLUTION TO THE PUNCTURE. THE PATIENT WENT TO SEE HER DOCTOR AND SHE WAS SENT TO (B)(6) HOSPITAL IN (B)(6). SHE RECEIVED AN X-RAY THAT VISUALIZED THE NEEDLE ABOUT 2 CM IN HER ABDOMEN. THE DECISION TO REMOVE THE NEEDLE SURGICALLY WAS MADE BUT THE DATE OF THE SURGERY WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833297 31 GX 8MM BD MICRO-FINE¿ INSULIN PEN NEEDLE INSULIN PEN NEEDLE FMI BECTON DICKINSON AND CO. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention