BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXPLUS CLR POSITIVE DISPLACEMENT CONN

    MDR report key: 10908822 · Received November 26, 2020

    Report

    Report Number
    9616066-2020-20451
    Event Type
    Malfunction
    Date Received
    November 26, 2020
    Date of Event
    November 3, 2020
    Report Date
    December 1, 2020
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 11/17/2020. H.6. INVESTIGATION: ONE MP1000C-0006 SAMPLE FROM LOT 20035317 WAS RECEIVED FOR INVESTIGATION WITH AN OPEN PACKAGING. ADDITIONALLY A 10 ML BD SYRINGE WAS RECEIVED CONNECTED TO THE SAMPLE TO ASSIST THE INVESTIGATION. A DETAILED VISUAL INSPECTION OF THE MP1000C-0006 SAMPLE DID NOT IDENTIFY SIGNS OF DAMAGE, CONTAMINATION OR MANUFACTURING DEFECT WHICH COULD HAVE CONTRIBUTED TO THE CUSTOMER'S EXPERIENCE. A REVIEW OF THE PRODUCTION RECORDS FOR LOT 20035317 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE RESULTED IN A REPORT OF THIS NATURE. IT WAS NOT POSSIBLE TO CONFIRM THE ROOT CAUSE OF THE REPORTED ISSUE IN THIS INSTANCE. ANALYSIS OF THE RETURNED SAMPLE DID NOT IDENTIFY ANY PRODUCT DEFECTS OR QUALITY DEVIATIONS THAT COULD HAVE CONTRIBUTED TO THE CUSTOMER¿S EXPERIENCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT MAXPLUS CLR POSITIVE DISPLACEMENT CONN HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DISCOLORATION/FOREIGN OBJECT IN THE STERILE BUNG UPON OPENING.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MAXPLUS CLR POSITIVE DISPLACEMENT CONN HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DISCOLORATION/FOREIGN OBJECT IN THE STERILE BUNG UPON OPENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1377701 MAXPLUS CLR POSITIVE DISPLACEMENT CONN INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 20035317

    Patients

    Seq Age Sex Outcome Treatment
    1