BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP PREP KITS

    MDR report key: 3875034 · Received June 16, 2014

    Report

    Report Number
    1416980-2014-19148
    Event Type
    Malfunction
    Date Received
    June 16, 2014
    Date of Event
    May 15, 2014
    Report Date
    May 23, 2014
    Manufacturer
    BAXTER HEALTHCARE - CALI
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). 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 TO BAXTER AND AN EVALUATION WAS COMPLETED. UPON VISUAL INSPECTION OF THE DEVICE, HOLES WERE NOTED IN THE FOIL OVERPOUCH OF THE PACKAGING. THIS ALLOWED AIR TO ENTER THE PACKAGING AND WAS A DIRECT CAUSE OF THE DRIED IODINE. THE CAUSE OF THE HOLES IN THE OVERPOUCH WAS DETERMINED TO BE A MANUFACTURING ISSUE. THE FOIL IS MANUFACTURED BY A SUPPLIER OUTSIDE OF BAXTER AND THE OVERPOUCH IS THEN SEALED AT A BAXTER PLANT. A SCAR WAS ISSUED TO THE MANUFACTURING FACILITY OF THE RAW MATERIAL. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MINICAP HAD ¿DRY IODINE.¿ THIS WAS DISCOVERED UPON OPENING THE PACKAGING OF THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 6 OF 7.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353407 MINICAP PREP KITS DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CALI SE12KD8

    Patients

    Seq Age Sex Outcome Treatment
    1