BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1ML BD SAFETY-LOK¿ U-100 INSULIN SYRINGE WITH 29G X 1/2" BD ULTRA-FINE¿ NEEDLE

    MDR report key: 6298233 · Received February 2, 2017

    Report

    Report Number
    1920898-2017-00012
    Event Type
    Malfunction
    Date Received
    February 2, 2017
    Date of Event
    November 6, 2016
    Report Date
    January 24, 2017
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K941657
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TWO LOT NUMBERS WERE PROVIDED FOR THE REPORTED INCIDENTS. THE INFORMATION FOR THESE LOT NUMBERS IS AS FOLLOWS: MEDICAL DEVICE LOT #: 5162602, MEDICAL DEVICE EXPIRATION DATE: N/A, DEVICE MANUFACTURE DATE: 6/11/2015. MEDICAL DEVICE LOT #: 5273604, MEDICAL DEVICE EXPIRATION DATE: N/A, DEVICE MANUFACTURE DATE: 9/30/2015. RESULTS: ONE SAMPLE OF LOT # 5273604 IN AN OPEN BLISTER PACK WAS RETURNED FOR EVALUATION. A SAMPLE OF LOT # 5162602 WAS NOT RETURNED. THE SYRINGE WAS RETURNED WITH THE HUB-NEEDLE/SHIELD ASSEMBLY SEPARATED FROM THE BARREL. A VISUAL INSPECTION REVEALED NO DAMAGE TO THE BARREL. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT NUMBERS 5162602 AND 5273604. CONCLUSION: THE RETURNED SAMPLE SHOWED A HUB AND NEEDLE SEPARATION BUT NO EVIDENCE OF DAMAGE TO THE SAFETY BARREL. AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED. HOWEVER, (B)(4) HAS BEEN OPENED TO ADDRESS THE CUSTOMER'S INDICATED FAILURE MODE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE THREE INCIDENTS ON (B)(6) 2016 IN WHICH A 1 ML BD SAFETY-LOK¿ U-100 INSULIN SYRINGE WITH 29 G X 1/2 IN. BD ULTRA-FINE¿ PERMANENTLY ATTACHED NEEDLE'S SAFETY MECHANISM BROKE OFF WHILE TRYING TO ACTIVATE IT AFTER USE. THERE WAS NO REPORT OF INJURIES OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79952 1ML BD SAFETY-LOK¿ U-100 INSULIN SYRINGE WITH 29G X 1/2" BD ULTRA-FINE¿ NEEDLE SAFETY ENGINEERED SYRINGE AND NEEDLE FMF BD MEDICAL - DIABETES CARE SECTION H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| O