BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 11087082 · Received December 29, 2020

    Report

    Report Number
    3002682307-2020-00428
    Event Type
    Malfunction
    Date Received
    December 29, 2020
    Date of Event
    September 24, 2020
    Report Date
    March 18, 2021
    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: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 1905207. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS SAMPLES WERE UNAVAILABLE FOR RETURN, TWENTY RETAINED SAMPLES OF THE SAME LOT NUMBER WERE OBTAINED FROM THE MANUFACTURING FACILITY FOR FURTHER EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE RETAINED SAMPLES, NO DEFECTS WERE IDENTIFIED. IT IS POSSIBLE THAT THIS INCIDENT RESULTED FROM A BLOCKAGE WITHIN THE ASSEMBLY MACHINE, CAUSING THE NEEDLE TO BECOME TRAPPED AND DAMAGED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE S2 10ML 21GA 1-1/2IN BD CHINA TIP WAS DEFECTIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN THE NURSE OPENING THE PACKAGE. IT WAS FOUND THAT THE NEEDLE TIP WAS DEFECT.

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE S2 10ML 21GA 1-1/2IN BD CHINA TIP WAS DEFECTIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN THE NURSE OPENING THE PACKAGE. IT WAS FOUND THAT THE NEEDLE TIP WAS DEFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1556110 SYRINGE S2 10ML 21GA 1-1/2IN BD CHINA SYRINGE FMF BECTON DICKINSON, S.A. 1905207

    Patients

    Seq Age Sex Outcome Treatment
    1