BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 31GA 8MM

    MDR report key: 11904960 · Received May 28, 2021

    Report

    Report Number
    1920898-2021-00617
    Event Type
    Malfunction
    Date Received
    May 28, 2021
    Date of Event
    May 4, 2021
    Report Date
    June 4, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES, D.10. RETURNED TO MANUFACTURER ON: 5/24/2021. H.6. INVESTIGATION: CUSTOMER RETURNED (10) 31GX8MM, 0.3ML INSULIN SYRINGES IN A SEALED POLYBAG FROM LOT# 0363881. CONSUMER STATED THAT THE 8MM SYRINGES ARE LONGER THAN HER PREVIOUS BOX. ALL 10 RETURNED SAMPLES WERE EXAMINED, THEN TESTED FOR NEEDLE LENGTH, POINT GEOMETRY, OUTER DIAMETER AND LUBE COVERAGE. IT WAS OBSERVED THAT 1 OUT OF THE 10 RETURNED SYRINGES EXHIBITED A CANNULA WITH AN UNEVEN BEVEL. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH #0363881. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS EXCEPT AS NOTED BELOW. THERE WERE TWO (2) NOTIFICATIONS NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. NO EXACT ROOT CAUSE DETERMINED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 BD SYRINGE 0.3ML 31GA 8MM CANNULA WAS TOO LONG. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER :   THE CONSUMER STATED THAT THE NEEDLES WERE LONGER THAN PREVIOUS ONES. DATE OF EVENT: UNKNOWN. SAMPLES: UNUSED SYRINGES AVAILABLE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS PENDING 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 1 BD SYRINGE 0.3ML 31GA 8MM CANNULA WAS TOO LONG. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER :   THE CONSUMER STATED THAT THE NEEDLES WERE LONGER THAN PREVIOUS ONES. DATE OF EVENT: UNKNOWN. SAMPLES: UNUSED SYRINGES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    798582 SYRINGE 0.3ML 31GA 8MM PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 0363881

    Patients

    Seq Age Sex Outcome Treatment
    1