BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 31GA 6MM WHOLEUNIT 10BAG

    MDR report key: 10550484 · Received September 17, 2020

    Report

    Report Number
    1920898-2020-01258
    Event Type
    Malfunction
    Date Received
    September 17, 2020
    Date of Event
    August 31, 2020
    Report Date
    November 3, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903249091
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: CUSTOMER RETURNED (100) 3/10CC, 6MM, 31G SYRINGES IN SEALED POLY BAGS WITH THE SHELF CARTON FROM LOT # 9252570. CUSTOMER STATES THAT THERE IS A GLUE ISSUE. THIRTY OUT OF 100 RETURNED SYRINGES WERE EXAMINED AND NO FOREIGN MATTER WAS OBSERVED ON ANY OF THE SAMPLES. NO DEFECTS WERE OBSERVED ON THESE SAMPLES. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9252570. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE FOUR (4) NOTIFICATIONS [200845676, 200845565, 200845567, 200845495] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. 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 ONE SYRINGE 0.3ML 31GA 6MM WHOLEUNIT 10BAG HAD A FOREIGN MATTER ON THE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED NEEDLE DEFECT OR GLUE ISSUES. VERBATIM: NEEDLE DEFECT OR GLUE ISSUES.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE SYRINGE 0.3ML 31GA 6MM WHOLEUNIT 10BAG HAD A FOREIGN MATTER ON THE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED NEEDLE DEFECT OR GLUE ISSUES. VERBATIM: NEEDLE DEFECT OR GLUE ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1016285 SYRINGE 0.3ML 31GA 6MM WHOLEUNIT 10BAG PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 324909 9252570 00382903249091

    Patients

    Seq Age Sex Outcome Treatment
    1 Other