BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 11435883 · Received March 8, 2021

    Report

    Report Number
    1416980-2021-01100
    Event Type
    Malfunction
    Date Received
    March 8, 2021
    Report Date
    April 8, 2021
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    PMA / PMN Number
    K192705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    CATALOGUE # IN THE INITIAL MDR IS BEING CORRECTED TO 5C4483 (PREVIOUSLY REPORTED AS 5C4482). G4: PMA/510K # OR BLA # IN THE INITIAL MDR IS BEING CORRECTED TO K192705 (PREVIOUSLY REPORTED AS K152675). THE DEVICE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED, AND IT WAS NOTED THAT THE FEMALE CONNECTOR WAS SEPARATED FROM THE MAIN BODY. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE REPORTED CONDITION WAS DETERMINED TO BE INADEQUATE SOLVENT APPLICATION TO THE SET DURING THE MANUFACTURING PROCESS. A NONCONFORMANCE HAS BEEN OPENED TO ADDRESS THIS ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED ON AN UNSPECIFIED DATE IN (B)(6) 2021. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A SEPARATION BETWEEN THE FEMALE CONNECTOR AND MAINBODY OF THE TRANSFER SET. IT WAS FURTHER DESCRIBED AS "DARK BLUE PIECE UNSCREWING FROM THE LIGHT BLUE PIECE". THIS OCCURRED DURING USE OF PERITONEAL DIALYSIS THERAPY. THE TRANSFER SET WAS REPLACED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334472 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1