BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1ML LS SP120

    MDR report key: 21707298 · Received March 27, 2025

    Report

    Report Number
    3003152976-2025-00106
    Event Type
    Malfunction
    Date Received
    March 27, 2025
    Date of Event
    March 20, 2025
    Report Date
    April 22, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    00382903031726
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6) FOLLOW UP MDR FOR DEVICE EVALUATION: ONE PHOTO WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, WHAT COULD BE A HAIR, AS INITIALLY REPORTED, IS OBSERVED WITHIN THE SYRINGE. WITHOUT THE PHYSICAL SAMPLE, THE COMPOSITION CANNOT BE VERIFIED, THEREFORE THE SPECIFIC ORIGIN CANNOT BE CONFIRMED AT THIS TIME. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 2210032, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS EVENT. SIX RETAINED SAMPLES OF THE REPORTED LOT WERE USED FOR ADDITIONAL EVALUATION. ALL PRODUCT WAS INSPECTED, NO HAIR OR OTHER CONTAMINATION WAS OBSERVED WITHIN ANY OF THE DEVICES. 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. WE HAVE REVIEWED OUR PRODUCTION AND INSPECTION RECORDS AND HAVE ESTABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT WITHOUT ISSUE. ALL INDIVIDUALS ARE REQUIRED TO FOLLOW PROPER GOWNING PROCEDURES BEFORE ENTERING THE ROOM, INCLUDING HAIR PROTECTION. WHILE WE CANNOT IDENTIFY A DIRECT ISSUE, IT IS LIKELY THIS INCIDENT OCCURRED DURING THE MANUFACTURING PROCESS. 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. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    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.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION

    Description of Event or Problem · 0

    DESCRIPTION: WHEN THE PATIENT WAS INJECTED, THE DOCTOR REMOVED THE SYRINGE TO WITHDRAW THE RANIBIZUMAB INJECTION, AND FOUND THERE WAS LITTLE HAIR IN THE SYRINGE, SO THE PATIENT COULDN 'T BE INJECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1407767 SYRINGE 1ML LS SP120 SYRINGE, PISTON FMF BECTON DICKINSON 2210032 00382903031726

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown