BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 10359446 · Received August 3, 2020

    Report

    Report Number
    1920898-2020-00977
    Event Type
    Malfunction
    Date Received
    August 3, 2020
    Date of Event
    July 13, 2020
    Report Date
    August 11, 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) 3/10CC, 8MM, 30G SYRINGES IN AN OPEN POLYBAG FROM LOT # 9176507. CUSTOMER STATES THAT WHEN REMOVING THE SHIELD, THE NEEDLE WITH THE SHIED WAS SEPARATED FROM THE HUB. BOTH RETURNED SYRINGES WERE TESTED AND THE HUB-NEEDLE ASSEMBLY DID NOT SEPARATE FROM THE BARREL WHEN THE SHIELD WAS REMOVED ON EITHER OF THE SYRINGES. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH #9176507. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS EXCEPT AS NOTED BELOW. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. 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 THAT 2 SYRINGE 0.3ML 30GA 8MM 7BAG 420CAS JP EXPERIENCED HUB SEPARATION FROM THE DEVICE WHICH WAS NOTED 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 30GA 8MM 7BAG 420CAS JP EXPERIENCED HUB SEPARATION FROM THE DEVICE WHICH WAS NOTED 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
    818768 SYRINGE 0.3ML 30GA 8MM 7BAG 420CAS JP SYRINGE FMF BD MEDICAL - DIABETES CARE 9176507

    Patients

    Seq Age Sex Outcome Treatment
    1 Other