BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 31GA 8MM HALFUNIT 10BG 500

    MDR report key: 11510024 · Received March 17, 2021

    Report

    Report Number
    1920898-2021-00310
    Event Type
    Malfunction
    Date Received
    March 17, 2021
    Date of Event
    February 19, 2021
    Report Date
    March 19, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382908440035
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: CUSTOMER RETURNED (34) LOOSE 3/10CC, 8MM SYRINGES. CUSTOMER STATES THAT THE SCALE PRINT SMUDGED. ALL RETURNED SYRINGES WERE EXAMINED AND ALL EXHIBITED SMUDGED INK WHERE SCALE MARKINGS WERE MISSING BETWEEN THE 0-10 UNIT MARKINGS. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0203537. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS EXCEPT AS NOTED BELOW. THERE WAS ONE (1) NOTIFICATION NOTED FOR DAMAGED TIPS CAUSING MISSING PRINT. ROOT CAUSE: TIMING WAS OFF CAUSING DAMAGED BARREL TIPS AND PRINT ISSUES. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 0.3ML 31GA 8MM HALFUNIT 10BG 500 HAD SCALE MARKING ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 328440 BATCH NO: 0203537. IT WAS REPORTED SCALE PRINT SMUDGED. VERBATIM: EMAIL RECEIVED, SCALE PRINT SMUDGED.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 0.3ML 31GA 8MM HALFUNIT 10BG 500 HAD SCALE MARKING ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 328440 BATCH NO: 0203537. IT WAS REPORTED SCALE PRINT SMUDGED. VERBATIM: EMAIL RECEIVED, SCALE PRINT SMUDGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403971 SYRINGE 0.3ML 31GA 8MM HALFUNIT 10BG 500 PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328440 0203537 00382908440035

    Patients

    Seq Age Sex Outcome Treatment
    1