BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML LL

    MDR report key: 21032797 · Received December 29, 2024

    Report

    Report Number
    3003152976-2024-00672
    Event Type
    Malfunction
    Date Received
    December 29, 2024
    Date of Event
    April 4, 2024
    Report Date
    April 15, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    00382903008650
    PMA / PMN Number
    K182589
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP MDR FOR DEVICE EVALUATION: ONE SAMPLE WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, A BLACK LINE WAS OBSERVED IN THE AREA WHERE THE SCALE SHOULD BE PRINTED, VERIFYING THE REPORTED INCIDENT. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2401119; NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED INCIDENT. FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE ARE SAMPLED AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURES. SIX RETAINED SAMPLES OF THE REPORTED LOT WERE USED FOR ADDITIONAL EVALUATION. ALL SYRINGES WERE INSPECTED, AND ALL SCALES WERE VERIFIED TO BE COMPLETE AND PROPERLY PRINTED ON THE BARREL. WHILE WE CANNOT IDENTIFY A DIRECT ISSUE, THIS INCIDENT LIKELY OCCURRED DURING THE MARKING PROCESS DUE TO A JAM IN THE MARKER WHICH PREVENTED THE SCALE FROM BEING PROPERLY PRINTED. MANUFACTURING PERSONNEL HAVE BEEN NOTIFIED OF THIS INCIDENT TO INCREASE AWARENESS. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED FOR FUTURE OCCURRENCE.

    Additional Manufacturer Narrative · 0

    ANNEX A CODE UPDATED TO A2101: DEVICE MARKINGS/LABELLING PROBLEM.

    Description of Event or Problem · 0

    TITLE/REF: SYRINGE 3P 60ML LL SYRINGE PUMP 300865. GEF : 3224. LABO : BD. LOT : 2401119. PER : 12/2028. EVENT DESCRIPTION: DURING THE PREPARATION OF A CHEMOTHERAPY BAG, THE PPH NOTICED WHEN UNWRAPPING THE SYRINGE THAT IT HAD NO GRADATION.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2429202 SYRINGE 50ML LL SYRINGE, PISTON FMF BECTON DICKINSON 2401119 00382903008650

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown