BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 3833307 · Received May 27, 2014

    Report

    Report Number
    1416980-2014-17034
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Report Date
    May 5, 2014
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A SAMPLE WAS RETURNED TO BAXTER AND THE EVALUATION IS COMPLETE. A VISUAL INSPECTION AND DIMENSIONAL ANALYSIS WAS PERFORMED. A CRACK WAS NOTED IN THE SAMPLE. THE DIMENSIONS WERE NOTED TO BE WITHIN SPECIFICATION. FUNCTIONAL TESTING WAS PERFORMED AND THE SAMPLE FAILED. THE REPORTED PROBLEM WAS CONFIRMED BUT THE CAUSE COULD NOT BE DETERMINED. A NOTIFICATION WAS ISSUED TO THE SUPPLIER. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS IS A REPORT OF A CUSTOMER WHO OBSERVED A CRACK ON A MINI-CAP DURING PERITONEAL DIALYSIS THERAPY. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY AND NO MEDICAL INTERVENTION RELATED TO THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310701 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - SWINFORD 13I12H15

    Patients

    Seq Age Sex Outcome Treatment
    1