BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3023531 · Received March 27, 2013

    Report

    Report Number
    1416980-2013-07438
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 11, 2013
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE SAMPLE WAS RETURNED FOR EVALUATION. VISUAL INSPECTION WAS PERFORMED, AND THE INTERLINK INJECTION SITE WAS FOUND TO BE FRACTURED AND SEPARATED FROM THE FEMALE LUER LOCK ADAPTER. MALE LUER OF THE INJECTION SITE REMAINED BONDED INSIDE THE FEMALE LUER LOCK ADAPTER. THE REPORTED CONDITION WAS CONFIRMED. THE ROOT CAUSE WAS NOT DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED. ADDITIONAL INFORMATION: A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS REPORTED TO BE AVAILABLE FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CATHETER EXT SET-(B)(4). BORE 2 ADAPTER Y-JUNCTION, HAD A LEAK FROM THE CONNECTION BETWEEN THE MALE LUER AND NON-BAXTER PRODUCT. THIS EVENT OCCURRED DURING INFUSION. THERE WAS PATIENT INVOLVEMENT; HOWEVER, IT IS UNKNOWN IF THERE WAS ANY PATIENT 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
    125637 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - SINGAPORE SR12J02051

    Patients

    Seq Age Sex Outcome Treatment
    1