BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXT SET DEHP FREE 1SS

    MDR report key: 11646322 · Received April 9, 2021

    Report

    Report Number
    9616066-2021-50691
    Event Type
    Malfunction
    Date Received
    April 9, 2021
    Date of Event
    March 15, 2021
    Report Date
    May 17, 2021
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    K960280
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO PRODUCT OR PHOTO WAS RETURNED BY THE CUSTOMER. IT WAS REPORTED THAT USER IS UNABLE TO PRIME SMARTSITE. THE CUSTOMER COMPLAINT 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 10010912 BECAUSE A LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. DUE TO NO SAMPLE BEING RECEIVED, AN INVESTIGATION COULD NOT BE PERFORMED AND A ROOT CAUSE COULD NOT BE DETERMINED. A TREND FOR THIS OCCLUSION ISSUE HAS BEEN IDENTIFIED FOR THIS PRODUCT LINE. A CAPA#1998036 HAS BEEN INITIATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT EXT SET DEHP FREE 1SS EXPERIENCED 1 CASE OF FLOW ISSUES AND 1 CASE OF BEING CLOGGED/BLOCKED/OCCLUDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 10010912. BATCH NO: UNKNOWN. UNABLE TO PRIME SMARTSITE.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT EXT SET DEHP FREE 1SS EXPERIENCED 1 CASE OF FLOW ISSUES AND 1 CASE OF BEING CLOGGED/BLOCKED/OCCLUDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 10010912. BATCH NO: UNKNOWN. UNABLE TO PRIME SMARTSITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541723 EXT SET DEHP FREE 1SS INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1