BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1ML DN 25GA 5/8 SP120

    MDR report key: 21934532 · Received April 30, 2025

    Report

    Report Number
    3003152976-2025-00168
    Event Type
    Malfunction
    Date Received
    April 30, 2025
    Date of Event
    April 16, 2025
    Report Date
    July 9, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    00382903031757
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 PHOTO AND PHYSICAL SAMPLE WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. UPON VISUAL INSPECTION, A SMALL HAIR WAS OBSERVED INSIDE THE SYRINGE, VERIFYING THE REPORTED INCIDENT. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 2210107, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS OBSERVATION. SIX RETAINED SAMPLED OF THE REPORTED LOT WERE USED FOR ADDITIONAL EVALUATION. ALL PRODUCT WAS INSPECTED, NO HAIR OR OTHER FOREIGN MATTER WAS OBSERVED WITHIN ANY OF THE PRODUCTS. MANUFACTURING FOR THIS PRODUCT IS PERFORMED IN A CLEAN ROOM WHICH IS KEPT UNDER A POSITIVE PRESSURE TO REDUCE THE CHANCE OF FOREIGN MATTER. 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. ALL INDIVIDUALS ARE REQUIRED TO FOLLOW PROPER GOWNING PROCEDURES BEFORE ENTERING THE ROOM, INCLUDING HAIR PROTECTION. WHILE WE CANNOT IDENTIFY A DIRECT ISSUE, IT WAS DETERMINED THIS EVENT WAS DUE TO PERSONNEL NOT FOLLOWING PROPER GOWNING PROCEDURES. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. MANUFACTURING PERSONNEL HAVE BEEN NOTIFIED OF THIS INCIDENT TO INCREASE AWARENESS OF THIS MATTER. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS.

    Description of Event or Problem · 0

    WE HAVE HAD TO RAISE A DEVIATION REGARDING A HAIR LIKE PARTICLE THAT WAS FOUND INSIDE A 1ML SYRINGE, ATL QMS NC (B)(4) HAS BEEN RAISED WITH REQUIREMENT FOR AN EXTERNAL INVESTIGATION. THE BATCH IS G136573, LOT: 10938429, BD BATCH: 2210107.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1242203 SYRINGE 1ML DN 25GA 5/8 SP120 SYRINGE, PISTON FMF BECTON DICKINSON 2210107 00382903031757

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown