BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 31GA 8MM 10BAG 500 WAL

    MDR report key: 11458175 · Received March 10, 2021

    Report

    Report Number
    1920898-2021-00284
    Event Type
    Malfunction
    Date Received
    March 10, 2021
    Date of Event
    February 11, 2021
    Report Date
    May 6, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00681131311786
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0083518. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGE 0.3ML 31GA 8MM 10BAG 500 WAL HAD FOREIGN MATTER BEFORE USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THERE IS LIQUID INSIDE BARRELS OF SYRINGES. VERBATIM: CONSUMER REPORTED LIQUID INSIDE OF THE BARREL OF HER SYRINGES. "

    Additional Manufacturer Narrative · 1

    "MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGE 0.3ML 31GA 8MM 10BAG 500 WAL HAD FOREIGN MATTER BEFORE USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THERE IS LIQUID INSIDE BARRELS OF SYRINGES. VERBATIM: CONSUMER REPORTED LIQUID INSIDE OF THE BARREL OF HER SYRINGES. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348508 SYRINGE 0.3ML 31GA 8MM 10BAG 500 WAL PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328512 0083518 00681131311786

    Patients

    Seq Age Sex Outcome Treatment
    1