BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Y EXT SET 20CM MACRO BORE SPIN NUT

    MDR report key: 10165909 · Received June 17, 2020

    Report

    Report Number
    9610847-2020-00181
    Event Type
    Malfunction
    Date Received
    June 17, 2020
    Date of Event
    May 25, 2020
    Report Date
    July 1, 2020
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    50382903851657
    PMA / PMN Number
    K142527
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 9091629 AND THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. TO AID IN THE INVESTIGATION OF THIS INCIDENT, ONE PICTURE SAMPLE WAS RECEIVED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE PICTURE, LEAKAGE WAS OBSERVED AT THE UNION OF THE TUBING AND THE Y COMPONENT. AT THIS TIME, A MANUFACTURING RELATED CAUSE COULD NOT BE IDENTIFIED FOR THIS INCIDENT. OUR QUALITY TEAM WILL CONTINUE TO MONITOR THE PRODUCTION PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE Y EXT SET 20CM MACRO BORE SPIN NUT LEAKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "EXTENSION SET LEAKED".

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE Y EXT SET 20CM MACRO BORE SPIN NUT LEAKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "EXTENSION SET LEAKED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629790 Y EXT SET 20CM MACRO BORE SPIN NUT INTRAVASCULAR ADMINISTRATION SET FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 385165 9091629 50382903851657

    Patients

    Seq Age Sex Outcome Treatment
    1 Other