BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 5ML SALINE FILL CHINA SP

    MDR report key: 10614532 · Received October 1, 2020

    Report

    Report Number
    1911916-2020-00915
    Event Type
    Malfunction
    Date Received
    October 1, 2020
    Date of Event
    September 8, 2020
    Report Date
    September 15, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    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 · 1

    (B)(4). INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED LOT NUMBER 9140782. 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 A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. INVESTIGATION CONCLUSION: OUR QUALITY TEAM WILL CONTINUE TO MONITOR THE MANUFACTURING PROCESS FOR THIS DEFECT AND OTHER EMERGING TRENDS. ROOT CAUSE DESCRIPTION: THE CAUSE OF THIS DEFECT COULD HAVE RESULTED DURING THE SYRINGE ASSEMBLY PROCESS, WHERE THE PLUNGER ROD-STOPPER ASSEMBLY INDUCED DAMAGE TO THE BARREL. RATIONALE: FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 5 ML SALINE FILL CHINA SP WAS DAMAGED. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AT 11:00 A.M. ON (B)(6) 2020, WHEN SEALING THE TUBE FOR THE PATIENT, THE FLUSH PACKAGE WAS OPENED, AND THE APPEARANCE OF THE FLUSH WAS FOUND TO BE DAMAGED, IMMEDIATELY REPLACED WITH A NEW ONE TO SEAL THE TUBE FOR THE PATIENT. DID NOT CAUSE ADVERSE HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1076539 SYRINGE 5ML SALINE FILL CHINA SP SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 9140782

    Patients

    Seq Age Sex Outcome Treatment
    1 Other