BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD INSULIN SYRINGE 0.3ML, 31G X 8MM

    MDR report key: 5259721 · Received December 1, 2015

    Report

    Report Number
    1920898-2015-00006
    Event Type
    Injury
    Date Received
    December 1, 2015
    Date of Event
    November 20, 2015
    Report Date
    February 24, 2016
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE CATALOG #: CATALOG NUMBER NOT SUBMITTED ON INITIAL MDR.

    Additional Manufacturer Narrative · 1

    THE EXACT DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY THE MANUFACTURER IS USED. THIS PRODUCT DOES NOT HAVE AN EXPIRATION DATE. EVALUATION: RESULT - A SAMPLE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO ABNORMALITIES DURING THE MANUFACTURE OF THE REPORTED LOT NUMBER 5180851. CONCLUSIONS - AS THERE WAS NO SAMPLE RETURNED FOR EVALUATION, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED. THE SAMPLE IS NOT AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT WHEN SHE INJECTED HER DOG, THE NEEDLE BROKE OFF AND REMAINED IN INJECTION SITE. THE CONSUMER BROUGHT HER DOG TO THE VETERINARIAN WHO SHAVED THE DOG'S FUR AT THE SITE AND TOOK AN X-RAY. THE NEEDLE WAS NOT OBSERVED ON X-RAY. THE VETERINARIAN TOLD THE CONSUMER HE DIDN'T THINK THE DOG WAS IN ANY DANGER AND TOLD THE CONSUMER TO WATCH FOR ANY BUMPS THAT MAY APPEAR NEAR THE SURFACE OF THE SKIN BECAUSE THAT COULD BE THE NEEDLE MOVING ALONG THE SURFACE. NO ADDITIONAL FOLLOW UP WAS REQUIRED AT THE TIME OF REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788035 BD INSULIN SYRINGE 0.3ML, 31G X 8MM INSULIN SYRINGE FMF BD MEDICAL - DIABETES CARE 5180851

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention