BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERLINK I.V. CATHETER EXTENSION SET

    MDR report key: 150510 · Received February 20, 1998

    Report

    Report Number
    6000001-1998-00119
    Event Type
    Injury
    Date Received
    February 20, 1998
    Date of Event
    January 1, 1998
    Report Date
    January 22, 1998
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FPA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ACCT. REPORTS THAT LUER SLIP ADAPTER SLIPPED OUT OF PERIPHERAL IV CATHETER. ACCT. STATES THEY USED THE APPROPRIATED TECHNIQUE OF INSERTING THE MALE LUER AND TWISTING IT. IN ADDITION THEY HAD THE CONNECTION TAPED. ACCT. STATES THE CHILD'S (3MOS.OLD) HBG. DROPPED 4 GMS. AS A RESULT OF THE DROP IN HBG., THE CHILD'S HOSPITAL STAY WAS EXTENDED. THIS WILL BE REPORTED AS A 30DAY MA. NO SAMPLES AVAILABLE. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERLINK I.V. CATHETER EXTENSION SET EXTENSION SET FPA BAXTER HEALTHCARE CORPORATION NA U413138R

    Patients

    Seq Age Sex Outcome Treatment
    1 3 MO Other