BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE

    MDR report key: 9403776 · Received December 3, 2019

    Report

    Report Number
    1920898-2019-01366
    Event Type
    Malfunction
    Date Received
    December 3, 2019
    Date of Event
    November 4, 2019
    Report Date
    December 12, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382908468039
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: CUSTOMER RETURNED ONE (1) LOOSE 31GX8MM, 0.5ML BD INSULIN SYRINGE. CONSUMER STATED: SHIELD WAS HARD TO REMOVE AND WHEN IT FINALLY CAME OFF, NEEDLE AND HUB ARE STUCK IN SHIELD. THE RETURNED SYRINGE WAS EXAMINED, AND IT WAS OBSERVED THAT THE SYRINGE EXHIBITED NEEDLE-HUB/SHIELD SEPARATION; NO DAMAGE TO THE BARREL TIP WAS OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 9063705 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. PROCESS SUMMARY: THE AUTOMATIC SYRINGE ASSEMBLY MACHINE FEEDS 0.5ML SYRINGE COMPONENTS (BARREL, STOPPER, PLUNGER, NEEDLE ASSEMBLY & CAP) AND ASSEMBLES THESE COMPONENTS. THIS MACHINE CONSISTS OF A BARREL CLEANING DIAL, LUBRICATION DIAL, PLUNGER/STOPPER ASSEMBLY DIAL, SYRINGE ASSEMBLY DIAL, AND VARIOUS INSPECTIONS AND TRANSFER DIALS. THERE WERE NO NOTIFICATIONS OR MAINTENANCE DISPATCHES DURING THE TIMEFRAME OF THIS BATCH THAT PERTAIN TO THIS DEFECT. ROOT CAUSE FOR THIS DEFECT CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE CONSUMER WAS UNABLE TO DELIVER MEDICATION WITH A BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NEEDLE AND HUB ARE STUCK IN SHIELD STATED, ITS NEVER HAPPENED BEFORE.

    Additional Manufacturer Narrative · 1

    A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE CONSUMER WAS UNABLE TO DELIVER MEDICATION WITH A BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NEEDLE AND HUB ARE STUCK IN SHIELD STATED, ITS NEVER HAPPENED BEFORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1201784 BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328468 9063705 00382908468039

    Patients

    Seq Age Sex Outcome Treatment
    1 Other