BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 6122105 · Received November 22, 2016

    Report

    Report Number
    1920898-2016-00043
    Event Type
    Malfunction
    Date Received
    November 22, 2016
    Date of Event
    November 7, 2016
    Report Date
    December 29, 2016
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K941657
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    RESULTS: TWO SEALED SAMPLES WERE RETURNED FOR EVALUATION. BOTH RETURNED SAMPLES WERE TESTED AND BOTH WERE ABLE TO ACTIVATE PROPERLY WITHOUT THE HUB-NEEDLE ASSEMBLY OR SLEEVE SEPARATING FROM THE BARREL. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 5162602. 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. HOWEVER, CAPA (B)(4) HAS BEEN OPENED TO ADDRESS NEEDLE PULLING OUT OF THE HUB AND SAFETY MECHANISM BREAK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SAFETY MECHANISM OF A 1ML BD SAFETY-LOK¿ U-100 INSULIN SYRINGE WITH 29 G X 1/2" BD ULTRA-FINE¿ NEEDLE CAME OFF AFTER INJECTION AND THE NEEDLE BROKE OFF IN USE. THE NEEDLE WAS REMOVED MANUALLY FROM THE PATIENT. THERE WAS NO INJURY TO THE PATIENT OR CLINICIAN AND NO MEDICAL INTERVENTIONS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771081 1ML BD SAFETY-LOK¿ U-100 INSULIN SYRINGE WITH 29 G X 1/2" BD ULTRA-FINE¿ NEEDLE SAFETY ENGINEERED SYRINGE AND NEEDLE FMF BD MEDICAL - DIABETES CARE 5162602

    Patients

    Seq Age Sex Outcome Treatment
    1 Other