BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 29GA 1/2IN 7BAG 420CAS JP

    MDR report key: 10389034 · Received August 10, 2020

    Report

    Report Number
    1920898-2020-01025
    Event Type
    Malfunction
    Date Received
    August 10, 2020
    Date of Event
    July 21, 2020
    Report Date
    September 1, 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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 8/7/2020. H.6. INVESTIGATION: CUSTOMER RETURNED (1) 3/10CC, 12.7MM, 29G SYRINGE IN AN OPEN POLY BAG FROM LOT # 9337437. CUSTOMER STATES THAT WHEN REMOVING THE SHIELD, THE NEEDLE WITH THE SHIED WAS SEPARATED FROM THE HUB. THE RETURNED SYRINGE WAS TESTED AND THE NEEDLE-HUB ASSEMBLY DID NOT SEPARATE 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 SYRINGE 0.3ML 29GA 1/2IN 7BAG 420CAS JP EXPERIENCED HUB SEPARATION FROM THE DEVICE PRIOR TO USE. 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

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 2 SYRINGE 0.3ML 29GA 1/2IN 7BAG 420CAS JP EXPERIENCED HUB SEPARATION FROM THE DEVICE PRIOR TO USE. 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
    853236 SYRINGE 0.3ML 29GA 1/2IN 7BAG 420CAS JP SYRINGE FMF BD MEDICAL - DIABETES CARE 9337437

    Patients

    Seq Age Sex Outcome Treatment
    1 Other