BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2233481 · Received September 2, 2011

    Report

    Report Number
    6000001-2011-22425
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    July 1, 2011
    Report Date
    August 10, 2011
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K101385
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: 6 COMPANION SAMPLES WERE AVAILABLE FOR EVALUATION FOR THE REPORTED CONDITION. DURING VISUAL INSPECTION NO DEFECTS WERE OBSERVED. THE SIX SAMPLES WERE WORKING WITHIN SPECIFICATION UNDER PRESSURE TEST AT 8PSI AND DURING FUNCTIONAL TEST. SINCE THE SETS WERE WORKING WITHIN SPECIFICATION, NO ASSIGNABLE ROOT CAUSE CAN BE IDENTIFIED. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS REPORTED TO BE AVAILABLE BUT HAS NOT BEEN RECEIVED FOR EVALUATION. A BATCH REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. IF ADDITIONAL INFORMATION BECOMES AVAILABLE OR THE SAMPLE IS RECEIVED, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER (B)(4) TO REPORT A DUAL LUER LOCK CAP THAT LEAKED AT THE CAP END, WHICH WAS USED FOR THE END CAP FOR A LINE. THE PROCESS STEP WAS DURING PATIENT USE; THEREFORE, THERE WAS PATIENT INVOLVEMENT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - AIBONITO

    Patients

    Seq Age Sex Outcome Treatment
    1