BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYR 0.3ML 30GA 8MM 7BAG 420CAS JP

    MDR report key: 10901668 · Received November 25, 2020

    Report

    Report Number
    1920898-2020-01632
    Event Type
    Malfunction
    Date Received
    November 25, 2020
    Date of Event
    November 2, 2020
    Report Date
    March 5, 2021
    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

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: THE INVESTIGATION WAS PERFORMED BASED ON THE PHOTOS PROVIDED. 2 PHOTOS OF 1 LOOSE 0.3ML SYRINGE WERE PROVIDED. THE CUSTOMER REPORTED WHEN REMOVING THE SHIELD, THE NEEDLE WITH THE SHIED WAS SEPARATED FROM THE BARREL. THE PHOTOS WERE REVIEWED, AND IT WAS OBSERVED THAT THE NEEDLE HUB/SHIELD ASSEMBLY WAS SEPARATED FROM THE BARREL; NO DAMAGE TO THE BARREL TIP WAS OBSERVED. A DEVICE HISTORY REVIEW COULD NOT BE COMPLETED AS NO BATCH NUMBER WAS PROVIDED. ROOT CAUSE FOR THIS DEFECT CANNOT BE DETERMINED. CAPA1630423 HAS BEEN OPENED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 SYR 0.3ML 30GA 8MM 7BAG 420CAS JP EXPERIENCED HUB SEPARATION FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN REMOVING THE SHIELD, THE NEEDLE WITH THE SHIED WAS SEPARATED FROM THE BARREL.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 3 SYR 0.3ML 30GA 8MM 7BAG 420CAS JP EXPERIENCED HUB SEPARATION FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN REMOVING THE SHIELD, THE NEEDLE WITH THE SHIED WAS SEPARATED FROM THE BARREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1365904 SYR 0.3ML 30GA 8MM 7BAG 420CAS JP SYRINGE FMF BD MEDICAL - DIABETES CARE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1