BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE-LINK

    MDR report key: 21719727 · Received March 28, 2025

    Report

    Report Number
    1416980-2025-01534
    Event Type
    Malfunction
    Date Received
    March 28, 2025
    Report Date
    April 29, 2025
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K132734
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4 LOT #: THE SUSPECT LOT WAS EITHER DR24I19055 OR DR23I28024. D4:EXPIRATION DATE/UDI #: INFORMATION FOR SUSPECT LOT DR24I19055: EXPIRATION DATE - 09/19/2029, UDI # - (B)(4). INFORMATION FOR SUSPECT LOT DR23I28024: EXPIRATION DATE - 09/29/2028, UDI # - (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    H4: DEVICE MANUFACTURE DATE: THE SUSPECT LOT DR23I28024 WAS MANUFACTURED ON 09/29/2023. THE SUSPECT LOT DR24I19055 WAS MANUFACTURED ON 09/20/2024. H11: THE ACTUAL DEVICE WAS NOT AVAILABLE; HOWEVER, TWO (02) PHOTOGRAPHS WERE AVAILABLE AND TWO (02) COMPANION SAMPLES WERE FUNCTIONALLY TESTED. VISUAL INSPECTION OF THE PHOTO IDENTIFIED A SET WHERE THE TUBING SEPARATED FROM THE LUER. A VISUAL INSPECTION OF THE TWO (2) COMPANION SAMPLES DID NOT IDENTIFY ANY ABNORMALITIES THAT CONTRIBUTED TO THE REPORTED CONDITION. FUNCTIONAL PRESSURE AND PULL TESTS WERE PERFORMED; NO LEAKS OR BLOCKAGES AND NO SEPARATION WERE NOTED IN THE SETS. THE REPORTED CONDITION WAS VERIFIED IN THE PHOTO SAMPLE. THE CAUSE OF THE SEPARATION COULD NOT BE DETERMINED. THE REPORTED CONDITION WAS NOT VERIFIED ON THE COMPANION SAMPLES. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THESE SUSPECT LOTS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TUBING SEPARATED FROM THE MALE LUER ON AN ONE-LINK NON-DEHP 3 LEAD MICROBORE CATHETER EXTENSION SET . THIS WAS OBSERVED DURING TUBING SIMULATION, PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2579555 ONE-LINK SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE CORPORATION 7N8332K ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown