BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD SAFETYGLIDE¿ THIN WALL; 8MM LENGTH, 31G

    MDR report key: 5660702 · Received May 17, 2016

    Report

    Report Number
    1920898-2016-00015
    Event Type
    Injury
    Date Received
    May 17, 2016
    Date of Event
    April 16, 2016
    Report Date
    May 4, 2016
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K951254
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE LOT # AND MEDICAL DEVICE EXPIRATION DATE. DEVICE MANUFACTURE DATE. THE ACTUAL DEVICE USED IN THIS INCIDENT IS UNKNOWN. UPON INQUIRY, TWO DIFFERENT POTENTIAL LOT NUMBERS WERE PROVIDED: LOT 5232762, MANUFACTURE DATE NOVEMBER 2015 PER DHR REVIEW, EXPIRATION DATE 08/31/2020. LOT 5205515, MANUFACTURE DATE OCTOBER 2015 PER DHR REVIEW, EXPIRATION DATE 07/31/2020. DEVICE EVALUATION: RESULTS- NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED FOR INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO ABNORMALITIES DURING THE MANUFACTURE OF THE REPORTED LOT NUMBERS 5232762 AND 5205515. CONCLUSION- WITHOUT A SAMPLE, THE COMPLAINT CANNOT BE CONFIRMED AND AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NURSE WAS ADMINISTERING INSULIN TO A PATIENT USING THE SUSPECT DEVICE. WHEN HE/SHE WENT TO PUSH THE SAFETY DEVICE UP, IT CAME OFF TRACK AND CAUSED THE NEEDLE TO COME UNDER THE SHIELD, RESULTING IN A NEEDLE STICK INJURY. THE NURSE WENT TO EMPLOYEE HEALTH FOR FOLLOW UP. BOTH THE PATIENT AND NURSE HAD POST EXPOSURE LAB WORK FOR (B)(6). ADDITIONAL LAB WORK FOR THE NURSE IS SCHEDULED FOR (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314274 BD SAFETYGLIDE¿ THIN WALL; 8MM LENGTH, 31G INSULIN SYRINGE AND NEEDLE FMF BD MEDICAL - DIABETES CARE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention