BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLUTION ADMINISTRATION SET

    MDR report key: 1940573 · Received December 29, 2010

    Report

    Report Number
    6000001-2010-06307
    Event Type
    Malfunction
    Date Received
    December 29, 2010
    Date of Event
    November 12, 2010
    Report Date
    December 6, 2010
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS RETURNED FOR EVALUATION; HOWEVER, IT HAS NOT YET BEEN COMPLETED. ONCE THE EVALUATION IS COMPLETE, A FOLLOW UP REPORT WILL BE SUBMITTED. THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT CONTAIN A US 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER RETURNED ONE ACTUAL SAMPLE FOR EVALUATION. THE SAMPLE WAS VISUALLY INSPECTED AND THE REPORTED CONDITION WAS CONFIRMED. THE SET WAS MISSING THE LUER LOCK. THERE WERE VISIBLE TRACES OF SOLVENT ON THE TUBING. A BATCH REVIEW WAS PERFORMED ON THE REPORTED LOT WITH NO DEVIATIONS FOUND. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. THE ASSIGNABLE ROOT CAUSE FOR THIS CONDITION COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER (B)(4) THAT ON (B)(6) 2010, A BAXTER SOLUTION ADMINISTRATION SET WAS FOUND WITH A MISSING LUER LOCK IN ITS PACKAGING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLUTION ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - MALTA 10F08V930M

    Patients

    Seq Age Sex Outcome Treatment
    1