BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3173480 · Received June 17, 2013

    Report

    Report Number
    1416980-2013-15602
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 23, 2013
    Report Date
    May 23, 2013
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    BRZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED AND REVEALED THAT ALL OF THE ACCEPTANCE CRITERIA WERE MET TO RELEASE THE LOT. IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE SAMPLE WAS NOT RETURNED FOR EVALUATION. HOWEVER, THE CUSTOMER DID PROVIDE PHOTOGRAPHS OF THE DEFECTIVE SAMPLE. INSPECTION OF THE PHOTOGRAPH IDENTIFIED THAT THE SEPTUM WAS COLLAPSED. THE CAUSE OF THE REPORTED CONDITION COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INJECTION PORT PUSHED INTO THE Y-SITE ON A BLOOD SOLUTION CONTINU-FLO SET WITH INTERLINK Y-SITE AND CHECK VALVE. THE PROCESS STEP THAT THIS MALFUNCTION OCCURRED IS UNKNOWN. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273547 ACCESS SET, ADMINISTRATION, INTRAVASCULAR BRZ BAXTER HEALTHCARE - SINGAPORE SR12J23032

    Patients

    Seq Age Sex Outcome Treatment
    1