BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAXZERO MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR

    MDR report key: 20317304 · Received September 27, 2024

    Report

    Report Number
    9616066-2024-01385
    Event Type
    Malfunction
    Date Received
    September 27, 2024
    Date of Event
    August 28, 2024
    Report Date
    October 21, 2024
    Manufacturer
    SISTEMAS MEDICOS ALARIS S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    10885403240621
    PMA / PMN Number
    K140831
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: IT WAS REPORTED THAT THE MALE LUER WAS LOOSE AND THERE WAS A LEAK. ONE SAMPLE MODEL MZ9226 WAS RETURNED FOR INVESTIGATION. THE SET WAS EXAMINED FOR DEFECTS AND ABNORMALITIES. NO DEFECTS OR ABNORMALITIES WERE OBSERVED. THE SET WAS CONNECTED TO A BD EXTENSION SET AND A 10 ML BD SYRINGE AND FLUSHED WITH WATER. NO LEAK WAS OBSERVED. AN AIR UNDER WATER TEST WAS PERFORMED AT ABOUT 10 PSI. NO LEAKAGE WAS OBSERVED. THE CUSTOMER COMPLAINT WAS UNABLE TO BE REPLICATED. THE ROOT CAUSE COULD NOT BE DETERMINED BECAUSE THE ISSUE COULD NOT BE REPLICATED. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED BECAUSE A LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD MAXZERO MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: DURING BEDSIDE SHIFT CHANGE REPORT; THIS RN TRACED ALL IV LINES AND NOTICED SOME MOISTURE ON LINES AND A TOWEL BENEATH IV LINES. DAY SHIFT RN NOTIFIED NIGHT SHIFT RN OF FINDINGS, BUT NO LEAK / SOURCE COULD BE DETECTED. A DRY CLOTH WAS PLACED BELOW ALL IV LINES AND LINES WERE WIPPED DRY. RN TRACED LINES AGAIN EACH HOUR, LOCATING VERY SLIGHT MOISTURE AT ONE SPOT. AT 1100 THE TOWEL BELOW THIS ISOLATED SPOT WAS WET. UPON INVESTIGATING THE TRI-FUSE CONNECTORS & ASSOCIATED IV LINES, THIS RN FOUND THAT THE MALE ADAPTER / CAP TO THE 'WHITE' LUMEN OF THE TRI-FUSE WAS LOOSE AT THE BASE OF THE CONNECTOR TO THE LINE. THE IV LINE WOULD SLIDE IN AND OUT OF THE BASE OF THE MALE ADAPTER; THUS ALLOWING THE INFUSING MED TO LEAK AT THIS SITE AND NOT INFUSE CORRECTLY. THE TRI-FUSE HAS BE SEQUESTERED ALONG WITH THIS KKS EVENT NUMBER.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1831109 BD MAXZERO MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS S.A. DE C.V. UNKNOWN 10885403240621

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown