BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2912171 · Received January 11, 2013

    Report

    Report Number
    1416980-2013-00966
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    December 1, 2012
    Report Date
    December 17, 2012
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K120443
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED AND IS NOT AVAILABLE FOR EVALUATION. A BATCH REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE SAMPLE WAS DISCARDED AND IS NOT AVAILABLE FOR EVALUATION; THEREFORE, THE CONDITION CANNOT BE CONFIRMED OR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE CAN NOT BE DETERMINED. A LABELING REVIEW WAS PERFORMED AND THE INSTRUCTIONS PRINTED ON EACH INDIVIDUAL PACKAGING ARE AVAILABLE TO THE USER AND ARE ACCURATE AND SUFFICIENT.

    Description of Event or Problem · 1

    A SALES REP SENT BAXTER CORPORATE PRODUCT SURVEILLANCE AN EMAIL TO REPORT A ONELINK MICROBORE CATHETER EXTENSION SET IN WHICH THE LUER DISCONNECTED FROM THE PATIENT'S HEPARIN LOCK ACCESS. ACCORDING TO THE REPORT, THE NURSE INADVERTENTLY FORGOT TO PERFORM A HALF TURN IN ORDER TO MAINTAIN THE CONNECTION OF THE ONELINK EXTENSION SET TO THE PATIENT'S HEPARIN LOCK ACCESS. SINCE THIS EVENT, THE NURSE HAS BEEN RETRAINED ON PROPER CONNECTION TECHNIQUE. THE EVENT OCCURRED DURING PATIENT USE. THERE WAS PATIENT INVOLVEMENT, BUT THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENTS ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19076 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - AIBONITO

    Patients

    Seq Age Sex Outcome Treatment
    1