BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEM V/NV 20D 1CV 2SS DEHP FREE

    MDR report key: 10411500 · Received August 14, 2020

    Report

    Report Number
    9616066-2020-02481
    Event Type
    Malfunction
    Date Received
    August 14, 2020
    Date of Event
    July 22, 2020
    Report Date
    July 23, 2020
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.
    Product Code
    FPA
    UDI-DI
    07613203021012
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE EXPECTED PRODUCT 2420-0007 OR PHOTO OF THE EVENT WAS NOT RETURNED BY THE CUSTOMER. INSTEAD ONE USED TUBING SET, MODEL # 2432-0007, WAS SENT IN BY THE CUSTOMER. THEREFORE, THE CUSTOMER COMPLAINT OF A HOLE IN THE 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 2420-0007 BECAUSE A VALID LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. DUE TO THE INCORRECT SAMPLE RECEIVED, AN INVESTIGATION COULD NOT BE PERFORMED AND A ROOT CAUSE COULD NOT BE DETERMINED. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE GEM V/NV 20D 1CV 2SS DEHP FREE EXPERIENCED LEAKAGE AND DEFECTIVE/DAMAGED TUBING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE HAD A COUPLE INSTANCES WHERE NURSING NOTICED A HOLE IN THE TUBING. THIS HAPPENED AGAIN YESTERDAY SO I HAD THEM SAVE THE TUBING WITH LOT #. THIS WAS HOOKED UP TO A PATIENT AND THEY NOTICED THAT THE IV FLUID WAS LEAKING ON THE FLOOR FROM A HOLE IN THE TUBING. I¿M NOT SURE IF ANYONE ELSE HAS MADE ANY COMPLAINTS BUT I DEFINITELY WANTED TO PASS ALONG SINCE THIS ISN¿T THE FIRST TIME THIS HAS HAPPENED.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE LOT #: AN INVALID LOT # OF 20036817 WAS PROVIDED. DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GEM V/NV 20D 1CV 2SS DEHP FREE EXPERIENCED LEAKAGE AND DEFECTIVE/DAMAGED TUBING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE HAD A COUPLE INSTANCES WHERE NURSING NOTICED A HOLE IN THE TUBING. THIS HAPPENED AGAIN YESTERDAY SO I HAD THEM SAVE THE TUBING WITH LOT #. THIS WAS HOOKED UP TO A PATIENT AND THEY NOTICED THAT THE IV FLUID WAS LEAKING ON THE FLOOR FROM A HOLE IN THE TUBING. I¿M NOT SURE IF ANYONE ELSE HAS MADE ANY COMPLAINTS BUT I DEFINITELY WANTED TO PASS ALONG SINCE THIS ISN¿T THE FIRST TIME THIS HAS HAPPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    872706 GEM V/NV 20D 1CV 2SS DEHP FREE INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C. SEE H.10 07613203021012

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 8015,8100, 20200722| 8015,8100, 20200722