BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 3222677 · Received July 12, 2013

    Report

    Report Number
    1416980-2013-18108
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Report Date
    June 18, 2013
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPANION SAMPLE WAS VISUALLY INSPECTED WITH NO ISSUES NOTED. THE SAMPLE WAS SQUEEZED FROM BOTH SIDES, BUT NO CRACK WAS FOUND. DURING UNDERWATER PRESSURE TESTING, NO FUNCTIONAL ISSUES WERE DETECTED. THE RETURNED MINICAP WAS HAND TIGHTENED ONTO A MOLD CORE IN ORDER TO CHECK FOR ANY CRACKS. HOWEVER, NO CRACKS WERE OBSERVED. THE REPORTED ISSUE WAS NOT CONFIRMED AND THE CAUSE COULD NOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED FOR ASSOCIATED LOT NUMBER GD893743 AND GD893446 WITH NO EXCEPTIONS NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. A COMPANION SAMPLE WAS REQUESTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS IS A REPORT OF A LEAK IN A MINICAP THAT OCCURRED DURING USE BY A PATIENT WHILE PERFORMING PERITONEAL DIALYSIS (PD) THERAPY. IT WAS REPORTED THAT IODINE WAS COMING FROM A CRACK IN THE MINI-CAP. THERE WAS PATIENT INVOLVEMENT; HOWEVER, THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION INDICATED WITH THE REPORTED CONDITION. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323255 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND

    Patients

    Seq Age Sex Outcome Treatment
    1