BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 10305861 · Received July 21, 2020

    Report

    Report Number
    1920898-2020-00907
    Event Type
    Malfunction
    Date Received
    July 21, 2020
    Date of Event
    June 30, 2020
    Report Date
    July 31, 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

    G.4. DATE RECEIVED BY MANUFACTURER: 7/10/2020.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: CUSTOMER RETURNED (1) LOOSE 3/10CC, 12.7MM SYRINGE. CUSTOMER STATES THAT A PLUNGER CAP WAS SEPARATED FROM THE PLUNGER ROD BEFORE USE. THE SYRINGE WAS RETURNED WITH THE PLUNGER CAP AND PLUNGER ROD SEPARATED FROM THE BARREL. NO DEFECTS WERE OBSERVED ON ANY COMPONENT OF THE RETURNED SAMPLE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9231316. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200842714] 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 THE SYRINGE 0.3ML 29GA 1/2IN 7BAG 420CAS JP EXPERIENCED A DAMAGED OR OPEN UNIT SEAL/SEAL WHERE STERILITY IS COMPROMISED. PRODUCT DEFECT WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A PLUNGER CAP WAS SEPARATED FROM THE PLUNGER ROD BEFORE USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYRINGE 0.3ML 29GA 1/2IN 7BAG 420CAS JP EXPERIENCED A DAMAGED OR OPEN UNIT SEAL/SEAL WHERE STERILITY IS COMPROMISED. PRODUCT DEFECT WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A PLUNGER CAP WAS SEPARATED FROM THE PLUNGER ROD BEFORE USE.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYRINGE 0.3ML 29GA 1/2IN 7BAG 420CAS JP EXPERIENCED A DAMAGED OR OPEN UNIT SEAL/SEAL WHERE STERILITY IS COMPROMISED. PRODUCT DEFECT WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A PLUNGER CAP WAS SEPARATED FROM THE PLUNGER ROD BEFORE USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770319 SYRINGE 0.3ML 29GA 1/2IN 7BAG 420CAS JP SYRINGE FMF BD MEDICAL - DIABETES CARE 9231316

    Patients

    Seq Age Sex Outcome Treatment
    1 Other