BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 29GA 1/2IN

    MDR report key: 10623835 · Received October 2, 2020

    Report

    Report Number
    1920898-2020-01345
    Event Type
    Malfunction
    Date Received
    October 2, 2020
    Date of Event
    September 4, 2020
    Report Date
    October 6, 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

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: CUSTOMER RETURNED (2) LOOSE 3/10CC, 12.7MM SYRINGES. CUSTOMER STATES THAT WHEN REMOVING THE SHIELD, THE NEEDLE WITH THE SHIED WAS SEPARATED FROM THE HUB. BOTH RETURNED SYRINGES WERE TESTED AND NO HUB ASSEMBLY SEPARATED FROM THE BARREL WHEN THE SHIELD WAS REMOVED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9337437. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS EXCEPT AS NOTED BELOW. THERE WAS ONE (1) NOTIFICATION [200863709} NOTED FOR OUT OF SPEC SHIELD PULL. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN REMOVING THE CAP FROM A SYRINGE 0.3ML 29GA 1/2IN THE NEED SEPARATED WITH THE CAP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN REMOVING THE SHIELD, THE NEEDLE WITH THE SHIED WAS SEPARATED FROM THE HUB."

    Additional Manufacturer Narrative · 1

    (B)(4). PMA / 510(K) #: THERE IS NO 510(K) FOR THIS DEVICE AS IT IS NOT SOLD IN THE US. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN REMOVING THE CAP FROM A SYRINGE 0.3ML 29GA 1/2IN THE NEED SEPARATED WITH THE CAP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN REMOVING THE SHIELD, THE NEEDLE WITH THE SHIED WAS SEPARATED FROM THE HUB."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1083036 SYRINGE 0.3ML 29GA 1/2IN SYRINGE FMF BD MEDICAL - DIABETES CARE 9337437

    Patients

    Seq Age Sex Outcome Treatment
    1 Other