BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONNECTION SHIELD

    MDR report key: 3170986 · Received June 14, 2013

    Report

    Report Number
    1416980-2013-15432
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 22, 2013
    Report Date
    May 22, 2013
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS REPORTED TO BE AVAILABLE BUT HAS NOT BEEN RECEIVED AT THIS TIME. SHOULD THE DEVICE BE RECEIVED OR ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. EVALUATION SUMMARY: THE DEVICE WAS RETURNED TO BAXTER FOR EVALUATION. UPON RECEIPT OF THE DEVICE IT WAS OBSERVED THAT A HOLE WAS PRESENT IN THE PACKAGING. VISUAL INSPECTION FOUND THAT THE FOAM SPONGE WAS ADHERED TO THE INNER SURFACE OF THE PACKAGING. IT WAS DETERMINED THAT THE IODINE DRIED DUE TO THE HOLE IN THE PACKAGING. HOWEVER, THE CAUSE OF THE HOLE IN THE POUCH COULD NOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IODINE IN THE CONNECTION SHIELD HAD DRIED UP AND THE CONNECTION SHIELD WAS STICKING TO THE PACKAGING. THIS WAS FOUND PRIOR TO USE. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 2 OF 2 FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271492 CONNECTION SHIELD SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - SWINFORD 12J18H10

    Patients

    Seq Age Sex Outcome Treatment
    1