BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 3ML LL 200 S/C

    MDR report key: 20275944 · Received September 22, 2024

    Report

    Report Number
    1213809-2024-00648
    Event Type
    Malfunction
    Date Received
    September 22, 2024
    Date of Event
    August 12, 2024
    Report Date
    September 25, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096573
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). FOLLOW UP MDR FOR DEVICE EVALUATION/CORRECTION CORRECTION: FOLLOWING SUBMISSION OF INITIAL MDR, THE CUSTOMER INFORMATION WAS NOT CORRECTLY REPORTED. SECTION E UPDATED TO REFLECT CORRECT CUSTOMER ADDRESS. EVALUATION: ELEVEN SAMPLES AND THREE PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, IT WAS OBSERVED THAT THE SCALE MARKING WAS ENTIRELY MISSING ON ALL SYRINGES. THE CONDITIONS OBSERVED ARE NON-CONFORMING PER PRODUCT SPECIFICATION. THE POTENTIAL ROOT CAUSE FOR THE MISSING PRINT DEFECT IS ASSOCIATED WITH THE MARKING PROCESS. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 4131473. THE PRODUCTION RECORDS SHOW A NOTIFICATION FOR THIS DEFECT WAS WRITTEN DURING THE PRODUCTION OF THIS BATCH. A REQUALIFICATION WAS PERFORMED, AND THE LINE WAS CLEARED OF DEFECTS. HOWEVER, IT IS POSSIBLE A LIMITED NUMBER OF PIECES WITH THIS CONDITION WERE ABLE TO ESCAPE DETECTION. A QUALITY ALERT WILL BE SENT TO THE PLANT TO ADDRESS THIS ISSUE.

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    MATERIAL # 309657 . BATCH # 4131473. IT WAS REPORTED THAT THE BD SYRINGE 3ML LL 200 S/C HAD A SCALE MARKING ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: RCC RECEIVED A COMPLAINT VIA PHONE. PIR ATTACHED. CUSTOMER STATES THAT THE SYRINGES ARE MISSING THE MARKINGS ON THEM. CUSTOMER STATES THAT THEY CANNOT TELL HOW MUCH LIQUID IS IN THE SYRINGE SINCE THERE ARE NO MARKINGS. CUSTOMER HAS A BAG OF 10-15 SYRINGES HE CAN RETURN FOR INVESTIGATION IF NEEDED. REF NUMBER: (B)(4); LOT NUMBER: 4131473.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1482843 BD SYRINGE 3ML LL 200 S/C PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 4131473 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown