BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 2080278 · Received May 6, 2011

    Report

    Report Number
    1423500-2011-05579
    Event Type
    Malfunction
    Date Received
    May 6, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 13, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD THE DEVICE BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE WAS RECEIVED FOR EVALUATION. THIS COMPLAINT OF LEAK WAS CONFIRMED BY EVALUATION DUE TO A CRACKED MINICAP. NO FUNCTIONAL TEST FAILURES WERE FOUND DURING IN-PROCESS QA TESTING DURING PRODUCTION OF THIS BATCH WHICH WOULD ACCOUNT FOR THE OCCURRENCE OF THIS TYPE OF PROBLEM, HOWEVER, KNIT LINE WEAKNESS WHICH CONTRIBUTED TO THIS FAILURE WAS DETECTED LATER. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM .THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    EMAIL NOTIFICATION OF COMPLAINT WAS SENT TO PRODUCT SURVEILLANCE SPECIALIST. CUSTOMER REPORTED SHE HAD PLACED A MINICAP ON THE CATHETER AND DURING THE DAY THE CAP LEAKED. SHE NOTICED THAT THE CAP HAD A CRACK IN IT. THE HOME PATIENT(HP) WAS CONTACTED ON (B)(6) 2011. THE HP STATED THAT THE MINICAP WAS IN PLACE FOR 12 HOURS BEFORE THE CRACK WAS DISCOVERED. THE HP USED PROPER CONNECTION TECHNIQUE BY TWISTING THE MINICAP CLOCKWISE ONTO THE TRANSFER SET CONNECTOR UNTIL FIRMLY SECURED . THE HP REPORTED THEY HAD DIFFICULTY WHEN PUTTING THE MINICAP ON THEIR TRANSFER SET, BUT SAID THEY DID NOT OVER TIGHTEN THE MINICAP WHEN THEY CONNECTED IT TO THE TRANSFER SET. THE HP HAD USED DILUTED BLEACH MIXTURE FOR CLEANING AND DISINFECTION. THERE WAS PATIENT INVOLVEMENT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINICAP SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE FKX BAXTER HEALTHCARE - MOUNTAIN HOME GD880757

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR HOMECHOICE