BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

    MDR report key: 3953547 · Received July 23, 2014

    Report

    Report Number
    1416980-2014-23908
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    June 30, 2014
    Report Date
    June 30, 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). (B)(6). EVALUATION SUMMARY: A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. VISUAL INSPECTION IDENTIFIED SMALL HOLES IN THE FOIL OVERPOUCH OF THE SAMPLE. THE CAUSE OF THE DRY IODINE WAS DETERMINED TO BE THE HOLES IN THE FOIL, WHICH ALLOWED AIR INTO THE PACKAGING. THE CAUSE OF THE HOLES IN THE FOIL WAS DETERMINED TO BE DEFECTIVE RAW MATERIAL. THE SUPPLIER OF THE FOIL WAS NOTIFIED TO ADDRESS THIS ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED UNUSED MINICAP PREP KIT, DRY IODINE WAS OBSERVED IN THE SPONGE OF THE MINICAP. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 21 OF 103.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430961 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CALI SE12KD8

    Patients

    Seq Age Sex Outcome Treatment
    1