BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAXZERO¿ MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR

    MDR report key: 16961504 · Received May 19, 2023

    Report

    Report Number
    2243072-2023-00828
    Event Type
    Malfunction
    Date Received
    May 19, 2023
    Date of Event
    April 20, 2023
    Report Date
    May 22, 2023
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    20885403240765
    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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: B5: DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT THE BD MAXZERO¿ MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR WAS DAMAGED. THIS IS 2 OF 2 RELATED EVENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE CUSTOMER THAT TWO QUAD-FUSE WERE BREAKING. D1: MEDICAL DEVICE BRAND NAME: BD MAXZERO¿ MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR. D2: MEDICAL DEVICE MANUFACTURER: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. D4: UDI #: (B)(4). D4: CATALOG #: MZ9275. D4: MEDICAL DEVICE LOT #: 22109216. D4: MEDICAL DEVICE EXPIRATION DATE: 12-OCT2025. H4: DEVICE MANUFACTURE DATE: 11-OCT-2022. G2: MANUFACTURING LOCATION: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. G.5. PMA / 510(K)#: K140831. D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 02-MAY-2023. H6: INVESTIGATION SUMMARY: THE CUSTOMER REPORTED THE QUADFUSES ARE BREAKING, AND RETURNED TWO USED SAMPLES. THE SAMPLES WERE BOTH DAMAGED AT THE MALE LUER COLLAR, WITH WHITENED PLASTIC AND CRACKS. ONE OF THE TWO HAD FALLEN OFF THE SET AS THE BACK END WAS CRACKED ENOUGH TO ALLOW SPACE FOR THE COLLAR TO FALL OFF. THE COMPLAINT IS VERIFIED. THE ROOT CAUSE IS NOT RELATED TO MANUFACTURING PROCESS, AND THE ROOT CAUSE IS NOT DEFINITIVELY KNOWN. THERE HAS BEEN A CONCERN IN THE PAST ABOUT USING ALCOHOL WIPES ON THE LUERS, CAUSING THEM TO BECOME BRITTLE. DEVICE HISTORY RECORD REVIEW FOR MODEL MZ9275 LOT NUMBER 22109216 WAS PERFORMED. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET.

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN FRANKLIN LAKES, NJ HAS BEEN LISTED IN SECTIONS D.3. AND G.1. AND THE FRANKLIN LAKES FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD MAXZERO¿ MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR WAS DAMAGED. THIS IS 2 OF 2 RELATED EVENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE CUSTOMER THAT TWO QUAD-FUSE WERE BREAKING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE UNSPECIFIED BD INFUSION SET WAS DAMAGED. THIS IS 2 OF 2 RELATED EVENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE CUSTOMER THAT TWO QUAD-FUSE WERE BREAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    852621 BD MAXZERO¿ MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 22109216 20885403240765

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown