BEUDAMED
    FDA Adverse Event Injury Summary report: N

    31 G X 5 MM BD ULTRA FINE¿ MINI INSULIN PEN NEEDLE

    MDR report key: 6298330 · Received February 2, 2017

    Report

    Report Number
    9616656-2017-00010
    Event Type
    Injury
    Date Received
    February 2, 2017
    Date of Event
    January 17, 2017
    Report Date
    May 10, 2017
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    K131358
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: A SAMPLE IS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 6061863. 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. IN THE EVENT THAT NEW, CHANGED, OR CORRECTED INFORMATION IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    RESULTS: SEVENTY TWO UNUSED AND SEALED SAMPLES WERE RETURNED FOR EVALUATION. THIRTY OF THE SEVENTY TWO DEVICES WERE EXAMINED AND NO BENT OR BROKEN CANNULA WAS OBSERVED. AS PREVIOUSLY REPORTED, A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 6061863. CONCLUSION: 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CONSUMER HAD A 31 G X 5 MM BD ULTRA FINE¿ MINI INSULIN PEN NEEDLE BREAK OFF IN HER ABDOMEN AND SHE REMOVED IT WITH HER FINGERS. A WEEK PRIOR TO THIS INCIDENT SHE HAD ANOTHER 31 G X 5 MM BD ULTRA FINE¿ MINI INSULIN PEN NEEDLE BREAK OFF DURING USE. THE CONSUMER WAS TAKEN TO A HOSPITAL BY HER SISTER AND RECEIVED AN X-RAY. AS OF THE DATE OF THIS REPORT, THE CONSUMER HAD NOT MADE BD AWARE OF THE RESULTS OF THE X-RAY. NO FURTHER INTERVENTIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79893 31 G X 5 MM BD ULTRA FINE¿ MINI INSULIN PEN NEEDLE INSULIN PEN NEEDLE FMI BECTON DICKINSON AND CO. 6061863

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention