BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AS SYR PSD MICROBORE

    MDR report key: 10878918 · Received November 20, 2020

    Report

    Report Number
    9616066-2020-20396
    Event Type
    Malfunction
    Date Received
    November 20, 2020
    Date of Event
    October 26, 2020
    Report Date
    November 9, 2020
    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
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF BIRTH: UNKNOWN. THE PATIENT¿S AGE WAS USED TO DETERMINE A PLACEHOLDER DATE FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN FDA DEVICE PROBLEM CODE: 1354. FDA PATIENT PROBLEM CODE: 2199. INVESTIGATION SUMMARY: A COMPLAINT OF A DAMAGED FEMALE LUER WAS RECEIVED FROM THE CUSTOMER. NO PRODUCT OR PHOTO WAS RETURNED BY THE CUSTOMER. THE CUSTOMER COMPLAINT OF DEFECTIVE TUBING COULD NOT BE VERIFIED DUE TO THE PRODUCT NOT BEING RETURNED FOR FAILURE INVESTIGATION. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED ON MODEL 10014914 BECAUSE A LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. INVESTIGATION CONCLUSION: THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. ROOT CAUSE DESCRIPTION: THE ROOT CAUSE OF THIS FAILURE WAS NOT IDENTIFIED AS NO PRODUCT WAS RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AS SYR PSD MICROBORE WAS CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 10014914 BATCH NO: UNKNOWN IT WAS REPORTED THAT THERE WAS A CRACKED FEMALE LUER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1344862 AS SYR PSD MICROBORE INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 10014914 UNKNOWN 50885403233904

    Patients

    Seq Age Sex Outcome Treatment
    1 6 MO