BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 2122474 · Received June 13, 2011

    Report

    Report Number
    1423500-2011-07554
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 20, 2010
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR AN INADEQUATE IODINE WAS NOT CONFIRMED DUE TO UNAVAILABLE SAMPLE. A BATCH REVIEW WAS NOT PERFORMED DUE TO UNKNOWN LOT NUMBER. A ROOT CAUSE WAS NOT IDENTIFIED DUE TO INSUFFICIENT INFORMATION. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    HOME CARE SERVICES (HCSR) CONTACTED (B)(4) TO REPORT A HOME PATIENT (HP) STATED THE AMOUNT OF POVIDONE IODINE IN THE SPONGES SEEM TO APPEAR LESS THAN USUAL IN EACH MINI CAP. HE STATED THE MINI CAPS USED TO HAVE MORE BETADINE SOLUTION IN THEM. HE REPORTED ABOUT (B)(6) SO FAR THAT HE HAS COME ACROSS. HCSR DOES NOT HAVE LOT NUMBER OR SAMPLE INFORMATION. THERE WAS PATIENT INVOLVEMENT, BUT NO INJURY OR MEDICAL INTERVENTION WAS REPORTED. NO ADDITIONAL INFORMATION WAS OBTAINED. BAXTER CONTACTED THE HP ON (B)(6) 2010 REGARDING THE REPORTED PROBLEM AND HE STATED THAT HE WAS CONCERNED IF IT WAS OK TO USE THE MINICAPS IF THERE WASN'T MUCH BETADINE PRESENT IN THE SPONGES. HE STATED THAT HE SEES COLOR IN THEM, BUT WASN'T SURE IF IT WAS ENOUGH FOR USE. HE STATED THAT HE IS USED TO SEEING IT ON THE INDIVIDUAL PACKAGES WHEN HE OPENED THEM FOR USE. HE STATED THAT THE MINICAP APPEARS DIFFERENT IN COLOR SOMETIMES AS HE GOES TO USE THEM. HE STATED THAT HE DOES NOT HAVE THE LOT NUMBER AVAILABLE AND MAY HAVE SOME COMPANION SAMPLES TO SEND IN. HE STATED THAT OTHERWISE EVERYTHING ELSE IS GOING FINE. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED. BAXTER CONTACTED THE HP REGARDING THE SAMPLE STATUS ON (B)(6) 2011 AND THE HP STATED THAT HE'S BEEN BUSY AND HASN'T HAD A CHANCE TO SEND THEM IN. HE THEN STATED THAT SINCE HE REALLY HAS NO FURTHER ISSUES, AND HAS NO IDEA WHERE HE KEPT THE SAMPLES, HE HAS DECIDED NOT TO SEND THEM IN. HE STATED EVERYTHING IS GOING WELL AND REPORTED NO INJURY OR MEDICAL INTERVENTION. ON (B)(6) 2011 (B)(4) CONTACTED THE HOME PATIENT (HP) REGARDING THE REPORT OF LESS IODINE THAN USUAL ON THE SPONGES. THE HP STATED HE HAD THE ISSUES WITH ABOUT/AT LEAST 30 MINICAPS. HE HAS BEEN USING THEM AND HAS NOT HAD ANY PROBLEMS AND WILL CALL AGAIN IF ANY OTHER PROBLEMS. THIS IS REPORT 14 OF 30.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1