BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLD/PIBA FW PCK 1ML

    MDR report key: 8688502 · Received June 11, 2019

    Report

    Report Number
    1416980-2019-03202
    Event Type
    Malfunction
    Date Received
    June 11, 2019
    Date of Event
    April 8, 2019
    Report Date
    August 14, 2019
    Manufacturer
    BAXTER HEALTHCARE ¿ ROUND LAKE
    Product Code
    LHI
    PMA / PMN Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION : THE ACTUAL DEVICE WAS NOT AVAILABLE; HOWEVER, A PHOTOGRAPH OF THE SAMPLE WAS PROVIDED FOR EVALUATION.  VISUAL INSPECTION WAS PERFORMED TO THE PHOTOGRAPH USING THE NAKED EYE WHICH REVEALED SOME OF THE MARKING APPEAR TO BE MISSING (0.7 MARKING AND HIGHER). BY THE NATURE OF THE SAMPLE, NO ADDITIONAL TESTS WERE PERFORMED. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION COULD NOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED OLD/PIBA FW PCK 1 ML WAS DEFECTIVE. IT WAS FURTHER SPECIFIED THAT THE SYRINGE WITH BLUE LABELING HAD VERY BAD ADHESION TO THE SURFACE AND THE NUMBERS AND GRADUATION MARKS WERE WORN OFF. THIS WAS NOTED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479954 OLD/PIBA FW PCK 1ML SET, I.V. FLUID TRANSFER LHI BAXTER HEALTHCARE ¿ ROUND LAKE NA 1713469

    Patients

    Seq Age Sex Outcome Treatment
    1