BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GP SERIES INFUSION SET, 1 SS Y

    MDR report key: 10714655 · Received October 21, 2020

    Report

    Report Number
    9616066-2020-20156
    Event Type
    Malfunction
    Date Received
    October 21, 2020
    Date of Event
    September 22, 2020
    Report Date
    November 24, 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
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO SAMPLES WERE RECEIVED FOR INVESTIGATION OF THE COMPLAINT; HOWEVER THE CUSTOMER HAS INDICATED THAT THE SPIKE TIP OF A 60693E PRODUCT WAS RECEIVED FROM THE PHARMACY BROKEN. FURTHER DETAILS RELATING TO THE CLINICAL SET UP AND SEQUENCE OF EVENTS PRIOR TO THE ISSUE OCCURRING WERE NOT AVAILABLE TO ASSIST THE INVESTIGATION. A REVIEW OF THE PRODUCTION RECORDS FOR LOT 1016447 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE CAUSED OR CONTRIBUTED TO A REPORT OF THIS NATURE. SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT GP SERIES INFUSION SET, 1 SS Y HAD A DAMAGED TIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: EQUIPMENT RECEIVED FROM PHARMACY WITH DAMAGED INSERTION TIP.

    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 GP SERIES INFUSION SET, 1 SS Y HAD A DAMAGED TIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: EQUIPMENT RECEIVED FROM PHARMACY WITH DAMAGED INSERTION TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1180601 GP SERIES INFUSION SET, 1 SS Y INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 1016447

    Patients

    Seq Age Sex Outcome Treatment
    1