BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIBORE BI-FUSE PRESSURE 2 IV CONNECTOR

    MDR report key: 11712892 · Received April 23, 2021

    Report

    Report Number
    9616066-2021-50796
    Event Type
    Malfunction
    Date Received
    April 23, 2021
    Date of Event
    March 4, 2021
    Report Date
    April 29, 2021
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    10885403230608
    PMA / PMN Number
    K140831
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A MZ5307 SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION OF THIS FEEDBACK; HOWEVER THE CUSTOMER INDICATES THAT A SEPARATION OCCURRED. NO FURTHER INFORMATION WAS AVAILABLE TO ASSIST THE INVESTIGATION IN THIS INSTANCE. A REVIEW OF THE PRODUCTION RECORDS FOR LOT 20075279 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE RESULTED IN A REPORT OF THIS NATURE. THE ROOT CAUSE OF THE CUSTOMER¿S EXPERIENCE COULD NOT BE DETERMINED IN THIS INSTANCE. WITHOUT A SAMPLE IT IS NOT POSSIBLE TO DETERMINE WHETHER A MANUFACTURING DEFECT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT MINIBORE BI-FUSE PRESSURE 2 IV CONNECTOR COMPONENT SEPARATED.THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FOLLOWS QUALITY DEVIATION FOR THE MATERIAL DOUBLE EXTENSOR W / MAXZERO BD CONNECTOR REF. ONE END CAME OFF WHEN THE DOCTOR PUNCTURED THE PATIENT IN THE CC.

    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 MINIBORE BI-FUSE PRESSURE 2 IV CONNECTOR COMPONENT SEPARATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FOLLOWS QUALITY DEVIATION FOR THE MATERIAL DOUBLE EXTENSOR W / MAXZERO BD CONNECTOR REF. ONE END CAME OFF WHEN THE DOCTOR PUNCTURED THE PATIENT IN THE CC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610482 MINIBORE BI-FUSE PRESSURE 2 IV CONNECTOR INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 20075279 10885403230608

    Patients

    Seq Age Sex Outcome Treatment
    1