BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 31GA 6MM HALFUNIT 10BAG

    MDR report key: 11362807 · Received February 22, 2021

    Report

    Report Number
    1920898-2021-00202
    Event Type
    Malfunction
    Date Received
    February 22, 2021
    Date of Event
    January 26, 2021
    Report Date
    February 12, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903249107
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0125301, MEDICAL DEVICE EXPIRATION DATE: 2025-05-31, DEVICE MANUFACTURE DATE: 2020-05-04. MEDICAL DEVICE LOT #: 0083507, MEDICAL DEVICE EXPIRATION DATE: 2025-04-30, DEVICE MANUFACTURE DATE: 2020-03-23. SAMPLES WERE RECEIVED AND AN INVESTIGATION WAS PERFORMED. THIS IS THE 1ST RELATED COMPLAINT FOR SCALE MISALIGNED ON LOT # 0125301. THIS IS THE 2ND RELATED COMPLAINT FOR SCALE MISALIGNED ON LOT # 0083507 A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT. BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE INDICATED ISSUE HENCE THE ROOT CAUSE IS UNDETERMINED. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) IS REQUIRED AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 4 SYRINGE 0.3ML 31GA 6MM HALFUNIT 10BAG HAD SCALE MARKING ISSUES BEFORE USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "THE VERY FIRST LINE IS LOWER THAN ZERO SCALE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257213 SYRINGE 0.3ML 31GA 6MM HALFUNIT 10BAG PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 324910 SEE H.10. 00382903249107

    Patients

    Seq Age Sex Outcome Treatment
    1