BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAXZERO MULTI-FUSE  EXTENSION SET WITH NEEDLELESS CONNECTOR

    MDR report key: 13577988 · Received February 22, 2022

    Report

    Report Number
    9616066-2022-00163
    Event Type
    Malfunction
    Date Received
    February 22, 2022
    Date of Event
    February 8, 2022
    Report Date
    February 28, 2022
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    20885403230629
    PMA / PMN Number
    K140831
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW COULD NOT BE COMPLETED AS NO BATCH NUMBER WAS PROVIDED. NO SAMPLES, PHOTOS OR PRODUCT INFORMATION AVAILABLE FOR EVALUATION. AS A RESULT, BD WAS UNABLE TO VERIFY THE REPORTED ISSUE OR DETERMINE A DEFINITIVE ROOT CAUSE AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD MAXZERO MULTI-FUSE  EXTENSION SET WITH NEEDLELESS CONNECTOR THE NEEDLE WAS CLOGGED AND CAUSED THE SYRINGE PUMP TO ALARM. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE BEEN HAVING ISSUES WITH OUR LIPIDS RINGING OFF OCCLUSION AND NOT INFUSING ON SYRINGE PUMPS ONLY WITH 60 ML SYRINGES.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD MAXZERO MULTI-FUSE  EXTENSION SET WITH NEEDLELESS CONNECTOR THE NEEDLE WAS CLOGGED AND CAUSED THE SYRINGE PUMP TO ALARM. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE BEEN HAVING ISSUES WITH OUR LIPIDS RINGING OFF OCCLUSION AND NOT INFUSING ON SYRINGE PUMPS ONLY WITH 60 ML SYRINGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    819985 BD MAXZERO MULTI-FUSE  EXTENSION SET WITH NEEDLELESS CONNECTOR INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. UNKNOWN 20885403230629

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown