BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAXZERO¿ MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR

    MDR report key: 16449705 · Received February 27, 2023

    Report

    Report Number
    9616066-2023-00274
    Event Type
    Malfunction
    Date Received
    February 27, 2023
    Date of Event
    January 25, 2023
    Report Date
    May 26, 2023
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    10885403240768
    PMA / PMN Number
    K140831
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL 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.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 27-FEB-2023. H6: INVESTIGATION SUMMARY: A COMPLAINT OF QUADFUSE BREAKING WHEN BEING REATTACHED TO THE PATIENT WAS RECEIVED FROM THE CUSTOMER. A SAMPLE WAS RECEIVED FOR INVESTIGATION. THROUGH VISUAL INSPECTION, THE CUSTOMER COMPLAINT WAS CONFIRMED. THE LUER WAS CRACKED. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED ON MODEL MZ9275 BECAUSE THE LOT NUMBER IS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD MAXZERO¿ MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR CRACKED WHEN REATTACHED TO THE PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "QUAD FUSE CRACKED WHEN BEING REATTACHED TO PATIENT BY NNP."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD MAXZERO¿ MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR CRACKED WHEN REATTACHED TO THE PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "QUAD FUSE CRACKED WHEN BEING REATTACHED TO PATIENT BY NNP."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    857136 BD MAXZERO¿ MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. UNKNOWN 10885403240768

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown