BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERLINK CONTINU-FLO, 3 INJECTION SITES, LUER LOCK, 105"

    MDR report key: 1943095 · Received December 30, 2010

    Report

    Report Number
    6000001-2010-06504
    Event Type
    Malfunction
    Date Received
    December 30, 2010
    Date of Event
    May 17, 2010
    Report Date
    May 17, 2010
    Manufacturer
    BAXTER HEALTHCARE - SHERBROOKE
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONDITION OF NO FLOW WAS CONFIRMED DUE TO HIGH CRACKING PRESSURE. TO ADDRESS THE HIGH CRACKING PRESSURE ISSUE, THE LABEL INSTRUCTIONS SPECIFY THAT THE BAG REQUIRES SQUEEZING IF THE SOLUTION DOES NOT FLOW. A BATCH REVIEW WAS PERFORMED AND NO DEVIATIONS WERE FOUND. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE; A FOLLOW UP MEDWATCH WILL BE SUBMITTED. THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT HAVE A US 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US. (B)(4).

    Description of Event or Problem · 1

    ONE ACTUAL SAMPLE WAS RETURNED FOR EVALUATION FOR THE CONDITION OF NO FLOW, AND WAS CONFIRMED. NO PATIENT INJURY OR MEDICAL INTERVENTION OCCURRED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERLINK CONTINU-FLO, 3 INJECTION SITES, LUER LOCK, 105" SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - SHERBROOKE ST10B170

    Patients

    Seq Age Sex Outcome Treatment
    1