BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAXGUARD¿ EXTENSION SET

    MDR report key: 16510546 · Received March 9, 2023

    Report

    Report Number
    9616066-2023-00372
    Event Type
    Malfunction
    Date Received
    March 9, 2023
    Date of Event
    February 3, 2023
    Report Date
    May 19, 2023
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    10885403236259
    PMA / PMN Number
    K051499
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 15-MAR-2023. H6: INVESTIGATION SUMMARY ONE USED SAMPLE MODEL ME2020, LOT 22109119 WAS RETURNED FOR INVESTIGATION. THE SET WAS EXAMINED FOR DEFECTS AND ABNORMALITIES. NO DEFECTS OR ABNORMALITIES WERE OBSERVED. THE SET WAS CONNECTED TO A 10 ML BD SYRINGE FILLED WITH WATER. THE SET WAS UNABLE TO BE PRIMED. VISUAL INSPECTION UNDER A MICROSCOPE REVEALED SIGNS OF EXCESS SOLVENT NEAR THE FEMALE LUER. A QUALITY NOTIFICATION WAS SENT TO THE MANUFACTURER. FROM THE MANUFACTURERS INVESTIGATION, THE USE OF AN INCORRECT PIN IS ACCEPTED AS THE ROOT CAUSE. AS A PREVENTIVE ACTION, THE QUALITY SAMPLING FOR THE OCCLUSION TEST WAS INCREASED, IN A PERIOD FROM APRIL 11 TO JUNE 30, 2023. AS A CORRECTIVE ACTION, THE USE OF PIN 1.4 IN MEDICA 9 WILL BE ENSURED, IN THE ME2020 MODEL, ACCORDING TO PROCEDURE. A DEVICE HISTORY RECORD REVIEW FOR MODEL ME2020 LOT NUMBER 22109119 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD MAXGUARD¿ EXTENSION SET TUBING WAS BLOCKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "TUBING BLOCKED".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD MAXGUARD¿ EXTENSION SET TUBING WAS BLOCKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "TUBING BLOCKED"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1630462 BD MAXGUARD¿ EXTENSION SET INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 22109119 10885403236259

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown