BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROBORE TRI-FUSE EXTENSION SET, 3 IV C

    MDR report key: 12183430 · Received July 16, 2021

    Report

    Report Number
    9616066-2021-51536
    Event Type
    Malfunction
    Date Received
    July 16, 2021
    Date of Event
    June 17, 2021
    Report Date
    July 19, 2021
    Product Code
    FPA
    UDI-DI
    50885403240780
    PMA / PMN Number
    K140831
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: THE CUSTOMER REPORTED LEAKING FROM THE LUER CONNECTION, AND RETURNED 3 USED MZ NEEDLELESS CONNECTORS, 2 MZ TRIFUSE SETS, AND 1 MZ TRIFUSE WITH FILTER (12 TOTAL MZ). THE SAMPLES WERE ALL TESTED AT THE MZ AND LUER CONNECTIONS, AND ONLY ONE ISSUE WAS FOUND. THE SAMPLES WERE TESTED TWO WAYS: UNDER 30 PSI WHILE UNDERWATER FOR 10 SECS TO CHECK FOR LEAKS IN THE FORM OF BUBBLES, AND PRIMED FROM A SYRINGE LOADED WITH BLUE DYE FLUID . ONE OF THE TRIFUSE MZ CONNECTIONS HAD A LEAK COMING FROM A CRACK, SEEN UNDER THE MICROSCOPE. THE ROOT CAUSE FOR THE CRACK IS UNKNOWN. NO OTHER FAILURE MODES WERE OBSERVED. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED ON MODEL MZ9266 BECAUSE A VALID LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE MICROBORE TRI-FUSE EXTENSION SET, 3 IV C EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IV SET LEAKING AT LUER AREA OF TUBING SET PER CUSTOMER.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MICROBORE TRI-FUSE EXTENSION SET, 3 IV C EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IV SET LEAKING AT LUER AREA OF TUBING SET PER CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1075973 MICROBORE TRI-FUSE EXTENSION SET, 3 IV C INTRAVASCULAR ADMINISTRATION SET FPA MZ9266 UNKNOWN 50885403240780

    Patients

    Seq Age Sex Outcome Treatment
    1