BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE S2 10ML 21GA 1-1/2IN BD CHINA

    MDR report key: 9970180 · Received April 16, 2020

    Report

    Report Number
    3002682307-2020-00133
    Event Type
    Malfunction
    Date Received
    April 16, 2020
    Date of Event
    March 26, 2020
    Report Date
    April 17, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 1902153 AND THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. TO FURTHER INVESTIGATE THIS ISSUE, THREE PICTURE SAMPLES WERE PROVIDED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE PICTURES, THE CANNULA COMPONENT WAS OBSERVED RUSTED. ALTHOUGH A DEFINITE CAUSE COULD NOT BE IDENTIFIED FOR THE RUSTED CANNULA, IT IS POSSIBLE THAT THIS INCIDENT RESULTED FROM IMPROPER STORAGE OF THE SYRINGES. THIS DEFECT CAN OCCUR IF THE SYRINGES ARE STORED TOO CLOSE TO DETERGENTS AND CLEANING PRODUCTS CONTAINING SODIUM HYPOCHLORITE OR OTHER SIMILAR CHEMICALS. AT THIS TIME FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE S2 10ML 21GA 1-1/2IN BD CHINA WERE RUSTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ON (B)(6) 2020, WHEN THE TEACHER CHEN FROM MICU OPENED A BOX OF 10ML SYRINGES FOR USE, HE FOUND THAT A LARGE NUMBER OF SYRINGES WERE RUST IN THE BOX.THE CUSTOMER WAS DISSATISFIED AND ASKED US TO COMPENSATE FOR A 10ML BOX OF SYRINGES."

    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 10ML 21GA 1-1/2IN BD (B)(4) WERE RUSTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ON (B)(6) 2020, WHEN THE TEACHER (B)(6) FROM MICU OPENED A BOX OF 10ML SYRINGES FOR USE, HE FOUND THAT A LARGE NUMBER OF SYRINGES WERE RUST IN THE BOX. THE CUSTOMER WAS DISSATISFIED AND ASKED US TO COMPENSATE FOR A 10ML BOX OF SYRINGES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434220 SYRINGE S2 10ML 21GA 1-1/2IN BD CHINA SYRINGE FMF BECTON DICKINSON, S.A. 1902153

    Patients

    Seq Age Sex Outcome Treatment
    1 Other