BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 20ML LL S/C 48

    MDR report key: 18564196 · Received January 23, 2024

    Report

    Report Number
    1911916-2024-00032
    Event Type
    Malfunction
    Date Received
    January 23, 2024
    Date of Event
    January 18, 2024
    Report Date
    February 29, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    30382903028307
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4): INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. H3 OTHER TEXT : SEE H10 MANUFACTURE NARRATIVE.

    Additional Manufacturer Narrative · 0

    PR (B)(4) FOLLOW UP. IT WAS REPORTED 20ML LUER LOK SYRINGES WERE LEAKING WHEN IN USE WITH HD MACHINES AND FOUND SOME SYRINGES DID NOT HAVE RUBBER STOPPER INSIDE THE SYRINGE BARREL. AS A SAMPLE WAS NOT RETURNED, A THOROUGH SAMPLE EVALUATION COULD NOT BE COMPLETED. TO AID IN THE INVESTIGATION, ONE VIDEO WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE VIDEO SHOWS A SYRINGE WITH A SOLUTION IN IT. WHEN THE SYRINGE IS TURNED UPSIDE DOWN, THE SOLUTION DRIPS OUT. NO OTHER INFORMATION COULD BE OBTAINED FROM THE VIDEO. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 302830, LOT 2242123. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. BASED ON THE INVESTIGATION AND WITH THE VIDEO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED, BUT WITHOUT THE ACTUAL PHYSICAL SAMPLE ANALYSIS A PROBABLE ROOT CAUSE COULD NOT BE OFFERED.

    Description of Event or Problem · 0

    THIS IS INCIDENT IS HAPPENS MORE THAN ONCE, BEFORE THIS INCIDENT YESTERDAY THEY FOUND 4 BD 20 LL SYRINGES WAS LEAKING WHEN USE AT HD MACHINES, AND BLOOD SPILL OVER AROUND THE FLOOR. AND TODAY THEY FOUND 1 BD 20 LL SYRINGES ALSO LEAKING. THEY TRIED TO CHECK NEW SYRINGE AND FOUND SOME SYRINGES DID NOT HAVE RUBBER STOPPER INSIDE THE SYRINGE BARREL

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED. THIS IS INCIDENT IS HAPPENS MORE THAN ONCE, BEFORE THIS INCIDENT YESTERDAY THEY FOUND 4 BD 20 LL SYRINGES WAS LEAKING WHEN USE AT HD MACHINES, AND BLOOD SPILL OVER AROUND THE FLOOR. AND TODAY THEY FOUND 1 BD 20 LL SYRINGES ALSO LEAKING. THEY TRIED TO CHECK NEW SYRINGE AND FOUND SOME SYRINGES DID NOT HAVE RUBBER STOPPER INSIDE THE SYRINGE BARREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    799605 SYRINGE 20ML LL S/C 48 SYRINGE, PISTON FMF BECTON DICKINSON 2242123 30382903028307

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown