BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2634891 · Received June 29, 2012

    Report

    Report Number
    6000001-2012-11979
    Event Type
    Malfunction
    Date Received
    June 29, 2012
    Date of Event
    May 29, 2012
    Report Date
    June 7, 2012
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K811078
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE CUSTOMER REPORTED CONDITION OF Y-TYPE CATH EXT SET/MALE LUER ADAPTER IN WHICH CUSTOMER OBSERVED LEAK AT JOINT OF Y CONNECTION WAS CONFIRMED DURING SAMPLE EVALUATION. ACTUAL DEFECTIVE SAMPLE WAS AVAILABLE FOR EVALUATION. DURING VISUAL INSPECTION NO DEFECTS WERE OBSERVED. SLIDE CLAMP WAS OPENED AND CLOSED; FEMALE LUER ADAPTER WAS ATTACHED TO FLUID SOURCE, ELIMINATING THE AIR. THE MALE LUER ADAPTER WAS INSERTED TO THE VASCULAR ACCESS DEVICE USING FIRM PUSH AND TWIST MOVEMENT TO ENSURE THE CONNECTION. THE SAMPLE FAILED DURING PRIMING AND DURING PRESSURE TEST AT 8PSI. THE ASSIGNABLE ROOT CAUSE OF THE REPORTED CONDITION IS UNKNOWN. ADDITIONAL INFORMATION: 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 FOR EVALUATION. A BATCH REVIEW CANNOT BE PERFORMED SINCE THERE WAS NO LOT NUMBER PROVIDED. IF THE SAMPLE IS RECEIVED OR ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BAXTER (B)(4) OF A Y-TYPE CATH EXT SET/MALE LUERADAPTER IN WHICH CUSTOMER OBSERVED LEAK AT JOINT OF Y CONNECTION. THE REPORTED CONDITION OCCURRED DURING PATIENT USE. A PATIENT WAS INVOLVED, BUT THERE IS NO REPORT OF PATIENT/USER INJURY OR MEDICAL INTERVENTION WAS NEEDED IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    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