BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AS SYR PSD MICROBORE

    MDR report key: 11084049 · Received December 28, 2020

    Report

    Report Number
    9616066-2020-20656
    Event Type
    Malfunction
    Date Received
    December 28, 2020
    Date of Event
    November 19, 2020
    Report Date
    January 15, 2021
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    50885403233904
    PMA / PMN Number
    K811885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: NO PRODUCT OR PHOTO WAS RETURNED BY THE CUSTOMER. THE CUSTOMER COMPLAINT OF LEAK AT BASE OF CALVE AND TOP OF SYRINGE COULD NOT BE VERIFIED DUE TO THE PRODUCT NOT BEING RETURNED FOR FAILURE INVESTIGATION. THE ROOT CAUSE OF THIS FAILURE COULD NOT BE IDENTIFIED WITHOUT A FAILURE INVESTIGATION. A DEVICE HISTORY RECORD REVIEW FOR MODEL 10014914 LOT NUMBER 20015796 WAS PERFORMED. THE SEARCH SHOWED THAT A TOTAL OF (B)(4) UNITS IN 1 LOT NUMBER WAS BUILT ON 09JAN2020. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT IV FLUID LEAKED FROM THE AS SYR PSD MICROBORE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IV FLUID FOUND ON FLOOR. LEAK OBSERVED AT BASE OF CLAVE AND TOP OF SYRINGE TUBING DURING INFUSION."

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IV FLUID LEAKED FROM THE AS SYR PSD MICROBORE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IV FLUID FOUND ON FLOOR. LEAK OBSERVED AT BASE OF CLAVE AND TOP OF SYRINGE TUBING DURING INFUSION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1539306 AS SYR PSD MICROBORE INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 10014914 20015796 50885403233904

    Patients

    Seq Age Sex Outcome Treatment
    1