BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1ML LS SP120

    MDR report key: 21368349 · Received February 12, 2025

    Report

    Report Number
    3003152976-2025-00051
    Event Type
    Malfunction
    Date Received
    February 12, 2025
    Date of Event
    February 7, 2025
    Report Date
    May 12, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    00382903031726
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP MDR FOR DEVICE EVALUATION: BOTH PHOTOS ALONG WITH SEVEN SAMPLES, WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, THE STOPPER IS OBSERVED TO BE SEPARATED FROM THE PLUNGER WITHIN TWO OF THE PROVIDED SAMPLES, VERIFYING THE REPORTED INCIDENT. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 2110123, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. SIX RETAINED SAMPLES OF THE SAME LOT WERE USED FOR ADDITIONAL EVALUATION. THE PRODUCT WAS INSPECTED, VERIFYING ALL STOPPERS WERE PROPERLY ASSEMBLED ONTO THE PLUNGER ROD AND NO DAMAGE OR DEFECTS WAS OBSERVED WITHIN THE PRODUCT. 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. A CAMERA SYSTEM IS USED IN THE ASSEMBLY MACHINE TO DETECT MISSING OR IMPROPERLY ASSEMBLED STOPPERS, THERE WERE NO INCIDENTS DOCUMENTED RELATED TO ANY FAILURES WITH THE DETECTION SYSTEM DURING MANUFACTURING OF LOT 2110123. WHILE WE CANNOT IDENTIFY A DIRECT ISSUE, IT IS POSSIBLE THE STOPPER WAS NOT PROPERLY ASSEMBLED DUE TO IMPROPER ALIGNMENT DURING ASSEMBLY. GIVEN THE DEVICE RECORDS DO NOT INDICATE ANY ISSUES, THIS CANNOT BE CONFIRMED AND A DEFINITIVE ROOT CAUSE CANNOT BE ESTABLISHED AT THIS TIME. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL BE MONITORED BY OUR QUALITY TEAM FOR SIGNS 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

    DETAILED INCIDENT DESCRIPTION: THEY USE 303172 FOR A THIN LIQUID USED TO LUBRICATE PIANO INSTRUMENT PARTS. IT HAS WORKED FLAWLESSLY FOR MANY YEARS, BUT THE SYRINGES IN THE BOX WITH LOT NUMBER: 2110123 HAVE CAUSED PROBLEMS. THEY OFTEN FIND THAT WHEN THEY HAVE EMPTIED THE SYRINGE OF LIQUID AND WANT TO PULL THE PLUNGER BACK AGAIN, THE RUBBER STOPPER COMES COMPLETELY OFF THE PLUNGER. WHEN DID THE INCIDENT OCCUR? DURING USE: NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    903741 SYRINGE 1ML LS SP120 SYRINGE, PISTON FMF BECTON DICKINSON 2110123 00382903031726

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown