BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CL NON-DEHP SOL SET 10 DPM .22FILTER 102" Y@6 W/2PC LL

    MDR report key: 2022377 · Received March 17, 2011

    Report

    Report Number
    6000001-2011-01949
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 22, 2011
    Report Date
    February 23, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K964850
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A SAMPLE IS NOT AVAILABLE FOR EVALUATION; THEREFORE, THE CONDITION CANNOT BE CONFIRMED OR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). 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. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND DURING THE MANUFACTURE OF THIS LOT.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BAXTER PRODUCT SURVEILLANCE OF A CLEAR LINK SET THAT HAD A HOLE AND WAS LEAKING RECLAST MEDICATION AT THE Y-SITE. THIS CLEARLINK SET WAS CONNECTED TO THE RECLAST VIAL. THIS REPORTED CONDITION OCCURRED DURING SETUP, AND THERE WAS NO PATIENT INJURY/MEDICAL INTERVENTION INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 2 OF 2 OF THE SAME REPORTED PROBLEM FROM THIS FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CL NON-DEHP SOL SET 10 DPM .22FILTER 102" Y@6 W/2PC LL SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE R10L10102

    Patients

    Seq Age Sex Outcome Treatment
    1 RECLAST VIAL