BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE S2 5ML 22GA 1-1/4IN BD CHINA

    MDR report key: 10048361 · Received May 12, 2020

    Report

    Report Number
    3002682307-2020-00152
    Event Type
    Malfunction
    Date Received
    May 12, 2020
    Date of Event
    April 22, 2020
    Report Date
    May 22, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 1902173 AND THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED INCIDENT. TO AID IN THE INVESTIGATION OF THIS ISSUE, TWO PICTURE SAMPLES WERE PROVIDED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE PICTURE SAMPLES, LEAKAGE WAS OBSERVED PAST THE PLUNGER ROD COMPONENT. TO FURTHER INVESTIGATE THIS ISSUE, OUR QUALITY TEAM OBTAINED TWENTY RETAINED SAMPLES OF THE SAME LOT NUMBER FROM THE MANUFACTURING FACILITY. THE RETAINED SAMPLES WERE ALL FUNCTIONALLY TESTED AND NO SIGNS OF LEAKAGE WERE OBSERVED. BASED ON THE PROVIDED CUSTOMER FEEDBACK, IT IS POSSIBLE THAT THE LEAKAGE RESULTED FROM DAMAGE TO THE PLUNGER LIP COMPONENT THAT MAY HAVE BEEN PRODUCED DURING THE MANUFACTURING OR ASSEMBLY PROCESS. OUR QUALITY TEAM WILL MONITOR THE PRODUCTION PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE S2 5ML 22GA 1-1/4IN BD CHINA LEAKED BLOOD DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN THE TEACHER USED A 5ML SYRINGE TO WITHDRAW BLOOD, SOME BLOOD LEAKED FROM THE GAP BETWEEN THE PLUNGER ROD AND THE SYRINGE.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE S2 5ML 22GA 1-1/4IN BD CHINA LEAKED BLOOD DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN THE TEACHER USED A 5ML SYRINGE TO WITHDRAW BLOOD, SOME BLOOD LEAKED FROM THE GAP BETWEEN THE PLUNGER ROD AND THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509998 SYRINGE S2 5ML 22GA 1-1/4IN BD CHINA SYRINGE FMF BECTON DICKINSON, S.A. 1902173

    Patients

    Seq Age Sex Outcome Treatment
    1 Other