BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 14089665 · Received April 12, 2022

    Report

    Report Number
    1416980-2022-01752
    Event Type
    Malfunction
    Date Received
    April 12, 2022
    Date of Event
    March 14, 2022
    Report Date
    July 8, 2022
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    UDI-DI
    00085412007731
    PMA / PMN Number
    K152675
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE SAMPLE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION WITH THE NAKED EYE AND MAGNIFICATION NOTED A CRACK IN THE LIGHT BLUE MAIN BODY AND ONE OF THE OCCLUDE FEET WAS BROKEN. FUNCTIONAL TESTING INCLUDING LEAK TESTING, CLEAR PASSAGE TESTING, AND CLAMP FUNCTION TESTING WERE PERFORMED; LEAK TESTING AND CLAMP FUNCTION TESTING IDENTIFIED A FLOW THROUGH THE SET WITH THE TWIST CLAMP IN CLOSED POSITION. NO ISSUES WERE NOTED DURING THE CLEAR PASSAGE TESTING. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION COULD NOT BE DETERMINED; HOWEVER, THE DAMAGED SET IS CONSISTENT WITH DAMAGE CAUSED BY EXPOSURE TO CHEMICAL AGENTS SUCH AS FOREIGN SOLVENTS, DYES, OR CLEANING AGENTS THAT DAMAGE THE TRANSFER SET MATERIALS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    H10: THE ACTUAL DEVICE WAS NOT AVAILABLE; HOWEVER TWO (2) PHOTOGRAPHS OF THE SAMPLE WERE PROVIDED FOR EVALUATION. THE PHOTOGRAPHS WERE VISUALLY INSPECTED WITH THE NAKED EYE AND A CRACKED MAIN BODY WAS OBSERVED. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION COULD NOT BE DETERMINED; HOWEVER, THE DAMAGED SET IS CONSISTENT WITH DAMAGE CAUSED BY EXPOSURE TO CHEMICAL AGENTS SUCH AS FOREIGN SOLVENTS, DYES, OR CLEANING AGENTS THAT DAMAGE THE TRANSFER SET MATERIALS. A NONCONFORMANCE HAS BEEN OPENED TO ADDRESS THIS ISSUE. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THERE WAS A CRACK ON THE LIGHT BLUE MAIN BODY OF A TRANSFER SET. THIS ISSUE WAS IDENTIFIED DURING USE OF THE DEVICE FOR PERITONEAL DIALYSIS THERAPY. 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
    1165074 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA H21I27074 00085412007731

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown