BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.5ML 29GA 1/2IN 7BAG 420CAS JP

    MDR report key: 10737794 · Received October 26, 2020

    Report

    Report Number
    1920898-2020-01476
    Event Type
    Malfunction
    Date Received
    October 26, 2020
    Date of Event
    October 5, 2020
    Report Date
    October 30, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: CUSTOMER RETURNED ONE (1) LOOSE 0.5ML BD INSULIN SYRINGE. THE CUSTOMER REPORTED ABOUT NEEDLE/SHIED SEPARATION FROM THE BARREL. THE RETURNED SYRINGE WAS EXAMINED, AND NEEDLE HUB SEPARATION WAS NOT OBSERVED; HOWEVER, ATTEMPTING TO REMOVE THE CANNULA SHIELD RESULTED IN THE NEEDLE HUB/SHIELD ASSEMBLY SEPARATING FROM THE BARREL. NO DAMAGE TO THE BARREL TIP WAS OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9252463. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [(B)(4)] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. PROCESS SUMMARY: AUTOMATIC SYRINGE ASSEMBLY MACHINE, WHICH 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. ROOT CAUSE: L2L DISPATCH WAS CREATED FOR HIGH HUBS. DEBRIS WAS COLLECTED ON THE DIAL. CORRECTIVE ACTION: CLEANED THE DEBRIS OUT OF THE DIAL. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYRINGE 0.5ML 29GA 1/2IN 7BAG 420CAS JP EXPERIENCED HUB SEPARATION FROM THE DEVICE PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER REPORTED ABOUT NEEDLE/SHIED SEPARATION FROM THE BARREL.

    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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYRINGE 0.5ML 29GA 1/2IN 7BAG 420CAS JP EXPERIENCED HUB SEPARATION FROM THE DEVICE PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER REPORTED ABOUT NEEDLE/SHIED SEPARATION FROM THE BARREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1203277 SYRINGE 0.5ML 29GA 1/2IN 7BAG 420CAS JP SYRINGE FMF BD MEDICAL - DIABETES CARE 9231037

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown