BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 31GA 6MM HALFUNIT 10BAG

    MDR report key: 8352172 · Received February 19, 2019

    Report

    Report Number
    1920898-2019-00184
    Event Type
    Malfunction
    Date Received
    February 19, 2019
    Date of Event
    January 30, 2019
    Report Date
    February 22, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: CUSTOMER RETURNED (8) 3/10CC, 6MM, 31G SYRINGES IN AN OPEN POLY BAG FROM LOT # 6242615. CUSTOMER STATES THAT THE VERY FIRST SCALE MARK IS WAY TOO LOWER THAN IT SHOULD BE. ALL RETURNED SYRINGES WERE TESTED USING THE PLUG GAUGE AND ALL PLACEMENTS OF THE SCALE MARKINGS FELL WITHIN SPECIFICATIONS. NO DEFECTS WERE OBSERVED ON THE SAMPLES. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 6242615. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 8 SYRINGES 0.3ML 31GA 6MM HALFUNIT 10BAG EXPERIENCED SCALE MARKING ISSUES WITH THE CUSTOMER STATING "THE VERY FIRST SCALE MARK IS WAY TOO LOWER THAN IT SHOULD BE."

    Additional Manufacturer Narrative · 1

    DEVICE EXPIRATION DATE: UNKNOWN. DATE OF EVENT: UNKNOWN. 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 8 SYRINGES 0.3ML 31GA 6MM HALFUNIT 10BAG EXPERIENCED SCALE MARKING ISSUES WITH THE CUSTOMER STATING "THE VERY FIRST SCALE MARK IS WAY TOO LOWER THAN IT SHOULD BE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143300 SYRINGE 0.3ML 31GA 6MM HALFUNIT 10BAG SYRINGE FMF BD MEDICAL - DIABETES CARE 6242615

    Patients

    Seq Age Sex Outcome Treatment
    1 Other