BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 0.5ML 31GA 6MM

    MDR report key: 15629093 · Received October 18, 2022

    Report

    Report Number
    1920898-2022-00715
    Event Type
    Malfunction
    Date Received
    October 18, 2022
    Date of Event
    September 20, 2022
    Report Date
    November 11, 2022
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER NAME AND ADDRESS: INITIAL REPORTER PHONE #: (B)(6). DEVICE EVALUATED BY MFR: A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: NO SAMPLES WERE RETURNED THEREFORE THE INVESTIGATION WAS PERFORMED BASED ON THE PHOTOS PROVIDED. THE CUSTOMER RETURNED AN IMAGE OF A 0.5ML, 31 GUAGE, 6MM SYRINGE. THE CUSTOMER REPORTED THAT THE NEEDLE WAS STUCK INSIDE THE SYRINGE. THE PHOTOS WERE EXAMINED, AND IT WAS OBSERVED THAT THE NEEDLE HUB/SHIELD ASSEMBLY WAS DETACHED FROM THE BARREL. NO DAMAGE TO THE BARREL TIP WAS OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 1172300. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. BASED ON THE PHOTO RECEIVED, EMBECTA WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF NEEDLE HUB SEPARATE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. CORRECTIVE ACTION: CAPA HAS BEEN COMPLETED WHICH ADDRESSES THIS ISSUE. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 0.5ML 31GA 6MM EXPERIENCED HUB SEPARATION FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEEDLE STUCK INSIDE THE SYRINGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 0.5ML 31GA 6MM EXPERIENCED HUB SEPARATION FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEEDLE STUCK INSIDE THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2386451 BD SYRINGE 0.5ML 31GA 6MM PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 1172300

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown