BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3093294 · Received May 6, 2013

    Report

    Report Number
    1416980-2013-11372
    Event Type
    Malfunction
    Date Received
    May 6, 2013
    Date of Event
    April 12, 2013
    Report Date
    April 17, 2013
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FRN
    PMA / PMN Number
    K880733
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. INITIAL EVALUATION CONFIRMED THE REPORTED CONDITION. UPON COMPLETION OF BAXTER'S INVESTIGATION, A FOLLOW-UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED THAT THE MALE LUER LOCK WAS BROKEN. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MALE LUER ON AN ANTI-SIPHON PCA EXTENSION SET WAS CRACKED. THE CRACK WAS LOCATED ON THE DISTAL END OF THE MALE LUER, HOWEVER, THE PROCESS STEP WAS UNKNOWN. IT IS UNKNOWN IF THERE WAS A PATIENT INVOLVED, HOWEVER, NO ADVERSE EVENT WAS REPORTED. THE SOURCE OF THE BLOOD, WITHIN THE SET, WAS UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196371 ACCESS PUMP, INFUSION FRN BAXTER HEALTHCARE - AIBONITO UR12G19100

    Patients

    Seq Age Sex Outcome Treatment
    1