BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE-LINK

    MDR report key: 21719728 · Received March 28, 2025

    Report

    Report Number
    1416980-2025-01533
    Event Type
    Malfunction
    Date Received
    March 28, 2025
    Report Date
    April 28, 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

    ADDITIONAL INFORMATION WAS ADDED TO H4, H6, H11. H4: DEVICE MANUFACTURE DATE: THE LOT DR23I28024 WAS MANUFACTURED ON 09/29/2023. THE LOT DR24I19055 WAS MANUFACTURED ON 09/20/2024. H11: THE ACTUAL DEVICE WAS NOT AVAILABLE; HOWEVER, FIVE (05) COMPANION SAMPLES WERE RECEIVED FOR EVALUATION. A VISUAL INSPECTION OF RETURNED COMPANION SAMPLES OBSERVED A SEPARATION BETWEEN TUBING AND SMALL BORE ASSEMBLY IN ONLY (03) THREE UNITS. A FUNCTIONAL TEST BY APPLYING 8 POUND PER SQUARE INCH, AND PULL TEST WERE PERFORMED ON THE FIVE RETURNED SAMPLES; NO LEAKS OR BLOCKAGES AND NO SEPARATION WERE NOTED IN THE UNITS. 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 THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN ONE-LINK NON-DEHP 3 LEAD MICROBORE CATHETER EXTENSION SET BROKE RESULTING IN A BLOOD LEAK; THE CENTRAL LINE WAS OPENED AND EXPOSED. THIS OCCURRED DURING PATIENT USE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2579556 ONE-LINK SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE CORPORATION 7N8332K ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNSPECIFIED CENTRAL LINE.