BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1/2 ML BD SAFETYGLIDE¿ INSULIN SYRINGE WITH 29 G X 1/2 IN. BD¿ NEEDLE

    MDR report key: 6424886 · Received March 22, 2017

    Report

    Report Number
    1920898-2017-00037
    Event Type
    Malfunction
    Date Received
    March 22, 2017
    Date of Event
    February 16, 2017
    Report Date
    April 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: ONE USED SAMPLE IN AN OPEN BLISTER PACK WAS RETURNED FOR EVALUATION. A VISUAL INSPECTION REVEALED THAT THE NEEDLE/HUB/SAFETY MECHANISM ASSEMBLY WAS SEPARATED FROM THE BARREL. NO DAMAGE TO THE BARREL WAS OBSERVED. THE RETURNED UNIT WAS FORWARDED TO THE MANUFACTURING SITE IN (B)(6), FOR FURTHER EVALUATION. CONCLUSION: A CONCLUSION IS NOT YET AVAILABLE AS THE SAMPLE IS STILL BEING EVALUATED. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    FURTHER EVALUATION BY THE MANUFACTURING SITE IN (B)(4) SHOWED THAT A REVIEW OF THE DEVICE HISTORY RECORD REVEALED ZERO DEFECTS NOTED DURING THE MANUFACTURING OF LOT # 6232682. OUR QUALITY ENGINEER NOTES THAT THE PROBABLE CAUSE FOR THE SEPARATED SAFETY MECHANISM IS THAT THERE WAS A PLUNGER OR OTHER SYRINGE COMPONENT CAUGHT IN THE MAIN DIAL OF THE ASSEMBLY EQUIPMENT. THIS PREVENTED THE SPRING FROM FULLY SNAPPING THE ADAPTER/PUSH ROD TO THE HUB.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AS A NURSE ACTIVATED THE SAFETY MECHANISM OF A 1/2 ML BD SAFETYGLIDE¿ INSULIN SYRINGE WITH 29 G X 1/2 IN. BD¿ PERMANENTLY ATTACHED NEEDLE, THE NEEDLE AND SAFETY MECHANISM FLEW OFF OF THE SYRINGE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208888 1/2 ML BD SAFETYGLIDE¿ INSULIN SYRINGE WITH 29 G X 1/2 IN. BD¿ NEEDLE SAFETY ENGINEERED INSULIN SYRINGE AND NEEDLE FMF BD MEDICAL - DIABETES CARE 6232682

    Patients

    Seq Age Sex Outcome Treatment
    1 Other