BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3041523 · Received April 8, 2013

    Report

    Report Number
    1416980-2013-08761
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    March 25, 2013
    Report Date
    March 25, 2013
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). A PHOTOGRAPH OF THE SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION OF THE PHOTOGRAPH REVEALED A CRACK ON THE SET'S BLUE CAP. THE REPORTED CONDITION WAS CONFIRMED. HOWEVER, THE ROOT CAUSE WAS NOT DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT THE SEAL ON AN INTERLINK SYRINGE ADAPTOR SET WAS SPLIT AND LEAKED WHEN IN USE. IT IS UNKNOWN DURING WHICH PROCESS STEP THIS EVENT OCCURRED. THERE IS NO REPORT OF PATIENT INVOLVEMENT, INJURY/ADVERSE EVENTS, OR MEDICAL INTERVENTION IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143052 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - MALTA 12D21V188

    Patients

    Seq Age Sex Outcome Treatment
    1