BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAXZERO MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR(S)

    MDR report key: 13588504 · Received February 23, 2022

    Report

    Report Number
    9616066-2022-00166
    Event Type
    Malfunction
    Date Received
    February 23, 2022
    Date of Event
    February 11, 2022
    Report Date
    July 22, 2022
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    20885403240727
    PMA / PMN Number
    K140831
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER FACILITY NAME: (B)(6) HOSPITAL. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: ONE MAXZERO CONNECTOR AND A 3ML SYRINGE WERE RECEIVED AND TESTED BY OUR QUALITY TEAM. THE MAX ZERO WAS INJECTED WITH SALINE THROUGH THE SYRINGE AND THE LEAK BETWEEN CONNECTOR AND SYRINGE WAS IMMEDIATELY NOTICED, VERIFYING THE COMPLAINT. THERE HAS BEEN A KNOWN ISSUE OF LEAKAGE BETWEEN THE 3ML SYRINGES AND MAXZERO SO THE COMPLAINT HAS BEEN VERIFIED. THE ROOT CAUSE IS NOT DUE TO THE MAXZERO BUT DUE TO THE SYRINGE SPECIFICALLY WHEN CONNECTED TO THE MAXZERO. THE PRODUCTION FACILITY IS AWARE OF THIS AND IS WORKING TO ELIMINATE FUTURE OCCURRENCES OF LEAKAGE WITH THIS CONNECTION. CAPA 1132752 HAS BEEN INITIATED. A DEVICE HISTORY RECORD REVIEW FOR MODEL MZ9267 LOT NUMBER 21105939 -WAS PERFORMED. THE SEARCH SHOWED THAT A TOTAL OF (B)(4) UNITS IN 1 LOT NUMBER WAS BUILT ON 20OCT2021. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE BUILD OF THIS SET. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD MAXZERO MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR(S) EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAD MEDICATION LINE LEAK.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD MAXZERO MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR(S) EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAD MEDICATION LINE LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129899 BD MAXZERO MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR(S) INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 21105939 20885403240727

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown