BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONNECTION SHIELD

    MDR report key: 3110010 · Received May 13, 2013

    Report

    Report Number
    1416980-2013-12214
    Event Type
    Malfunction
    Date Received
    May 13, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 22, 2013
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDJ
    PMA / PMN Number
    K895673
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: A REVIEW OF ALL BATCH RECORD DOCUMENTS FOR POTENTIALLY ASSOCIATED LOT NUMBER GD893594 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. DURING VISUAL INSPECTION OF THE RETURNED SAMPLE IT WAS NOTICED THAT THE CONNECTION SHIELD WAS ADHERED TO THE PACKAGING POUCH AND HAD A MISSING/BROKEN CLASP. THE CAUSE OF THE REPORTED CONDITION CANNOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD THE DEVICE BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT A MINICAP WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210398 CONNECTION SHIELD SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - CLEVELAND GD893594

    Patients

    Seq Age Sex Outcome Treatment
    1