BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 3952317 · Received July 23, 2014

    Report

    Report Number
    1416980-2014-23812
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Report Date
    June 30, 2014
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE MANUFACTURING DATE FOR THIS LOT IS 04/11/2014 - 04/17/2014. A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS CONDUCTED 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. THE DEVICE WAS RETURNED AND EVALUATED. THE VISUAL INSPECTION WAS CONDUCTED ON THE MINICAP AND ALTHOUGH THE SPONGE WAS PARTIALLY STICKING UP IN THE CAP, THE REPORTED EVENT COULD NOT BE VERIFIED BECAUSE THIS IS NOT AN ACTUAL DEFECT. THERE IS NO SPECIFIED REQUIREMENT FOR SPONGE SUBMERSION/PLACEMENT. THE PRESENCE OF IODINE WAS DETECTED ON THE SPONGE AND THE MINICAP WAS DETERMINED TO HAVE MET PRODUCT SPECIFICATIONS. IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SPONGE WAS STICKING OUT OF THE MINICAP. THE EVENT WAS OBSERVED BEFORE USE. THE CALLER STATED THERE WAS NO DAMAGED TO THE POUCH OR THE BOX THE PRODUCT WAS DELIVERED IN. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AS A RESULT OF THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 2 OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430883 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND GD896845

    Patients

    Seq Age Sex Outcome Treatment
    1