BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING TITANIUM ADAPTER

    MDR report key: 2950521 · Received February 8, 2013

    Report

    Report Number
    1416980-2013-03305
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 29, 2013
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDJ
    PMA / PMN Number
    K894783
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS REPORTED TO BE AVAILABLE FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). MANUFACTURING RECORDS FOR THE BATCH WERE REVIEWED AND NO ISSUES RELATING TO THE COMPLAINT WERE NOTED. THE REPORTED CONDITION WAS CONFIRMED BASED ON EVALUATION OF THE SAMPLE RECEIVED. THE SAMPLE WAS VISUALLY INSPECTED AND IT APPEARS AS IF THE POUCH HAD BEEN PEELED OPEN. THERE WAS EVIDENCE THAT ALL SEALS WERE PRESENT AT THE TIME OF SHIPMENT FROM THE MANUFACTURING FACILITY. NO ROOT CAUSE WAS DETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BAXTER CORPORATE PRODUCT SURVEILLANCE A LOCKING TITANIUM ADAPTOR IN WHICH THE PACKAGING WAS OPENED. ACCORDING TO THE REPORT, THE SEAL WAS FOUND TO ALREADY BE OPENED WHEN THE CASE OF PRODUCT WAS OPENED. THE ALLEGED DEFECT WAS OBSERVED BEFORE USE. THEREFORE THERE WERE NO REPORTS OF PATIENT INJURY, ADVERSE EVENTS, OR MEDIAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53815 LOCKING TITANIUM ADAPTER SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - SWINFORD 12C29H35

    Patients

    Seq Age Sex Outcome Treatment
    1