BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NI

    MDR report key: 14429139 · Received May 18, 2022

    Report

    Report Number
    1416980-2022-02478
    Event Type
    Malfunction
    Date Received
    May 18, 2022
    Date of Event
    April 22, 2022
    Report Date
    June 17, 2022
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    PMA / PMN Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE RETURNED DEVICE HAS A D1: BRAND NAME OF MINICAP TRANSFER SET, A D4: CATALOGUE # OF 5C4482, AND A G4: PMA/510K # OF K152675. H10: THE DEVICE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION WITH THE NAKED EYE IDENTIFIED A SEPARATION BETWEEN THE FEMALE CONNECTOR AND MAIN BODY AND DAMAGED SILICONE TUBING. FUNCTIONAL TESTING INCLUDING LEAK, CLEAR PASSAGE AND CLAMP FUNCTION TESTING WERE PERFORMED; LEAK TESTING NOTED A LEAK FROM THE DAMAGED SILICONE TUBING LOCATED AT THE LEG OF THE FEMALE CONNECTOR. THE REPORTED CONDITION OF SEPARATION BETWEEN THE FEMALE CONNECTOR AND MAIN BODY WAS VERIFIED. THE CAUSE OF THE SEPARATION WAS MANUFACTURING RELATED DUE TO INADEQUATE SOLVENT TO THE SET. THE CAUSE OF THE DAMAGED SILICONE TUBING COULD NOT BE DETERMINED; HOWEVER THE MOST PROBABLE CAUSE IS USER RELATED WHEN ATTEMPTING TO DISCONNECT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A SEPARATION BETWEEN THE FEMALE CONNECTOR (DARK BLUE PART) AND THE MAIN BODY (LIGHT BLUE PART) OF THE TWIST CLAMP ON A MINICAP EXTENDED LIFE PD TRANSFER SET. THIS OCCURRED WHILE DISCONNECTING FROM PERITONEAL DIALYSIS THERAPY. THE TRANSFER SET WAS REPLACED. THERE WAS NO REPORT OF 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
    1502881 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown