BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 2150819 · Received July 6, 2011

    Report

    Report Number
    1423500-2011-08706
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 22, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IF THE SAMPLE IS RECEIVED FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF BAXTER'S INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT WAS CONFIRMED IN THE LAB AS A SEPARATED PROTECTIVE CAP, DISCOVERED BEFORE SET USE. FROM TIME TO TIME CAPS CAN BECOME LOOSE IN THE POUCH DUE TO HANDLING. THIS IS A RELATIVELY RARE OCCURRENCE. THIS CAN OCCUR AFTER MANUFACTURING, IN SHIPPING OR AT THE CUSTOMER OR PROVIDER. THERE IS NO RISK TO THE PATIENT SINCE THEY ARE INSTRUCTED TO NOT USE THE SET IF CAPS ARE LOOSE. THE CAUSE WAS UNDETERMINED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER PRODUCT SURVEILLANCE ON (B)(6) 2011 A TRANSFER SET IN WHICH "THE CAP WAS DISCONNECTED WHEN IT WAS OPENED." PRODUCT SURVEILLANCE CONTACTED THE NURSE REGARDING THE TRANSFER SET WITH THE CAP NOT ON IT, AND SHE STATED THAT IT HAD NOT BEEN USED ON A PATIENT. THE NURSE SAID THAT SHE WOULD HOLD THE SAMPLE FOR EVALUATION. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME H10K05047

    Patients

    Seq Age Sex Outcome Treatment
    1