BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIV BUNDLE KIT

    MDR report key: 19105553 · Received April 15, 2024

    Report

    Report Number
    3004519921-2024-00022
    Event Type
    Injury
    Date Received
    April 15, 2024
    Date of Event
    March 18, 2024
    Report Date
    May 23, 2024
    Manufacturer
    MEDLINE INDUSTRIES LP
    Product Code
    LRS
    UDI-DI
    00653160364286
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATE TO H6- INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE CUSTOMER, THERE HAVE BEEN MULTIPLE INCIDENCES WHERE A "LEAKAGE" IS OCCURRING DUE TO THE "GREEN PIECE" BREAKING ON THE IV. THE CUSTOMER REPORTED WHEN THE INCIDENT OCCURS, THEY "ATTEMPT TO SAVE THE LINE" BUT "UP TO 90%" OF THE DEVICES THAT FAIL REQUIRE A NEW IV TO BE INSERTED. THE CUSTOMER REPORTED THERE HAS BEEN NO SERIOUS INJURY, MEDICAL INTERVENTION, OR FOLLOW UP CARE RELATED TO THE REPORTED INCIDENT. NO ADDITIONAL INFORMATION IS AVAILABLE. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR AGAIN. IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ACCORDING TO THE CUSTOMER, THERE HAVE BEEN MULTIPLE INCIDENCES WHERE A "LEAKAGE" IS OCCURRING DUE TO THE "GREEN PIECE" BREAKING ON THE IV.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1509696 PIV BUNDLE KIT LRS MEDLINE INDUSTRIES LP 2023071090 00653160364286

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other