BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 13970645 · Received March 31, 2022

    Report

    Report Number
    1416980-2022-01483
    Event Type
    Malfunction
    Date Received
    March 31, 2022
    Date of Event
    March 1, 2022
    Report Date
    July 14, 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
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER FACILITY NAME : (B)(6) HOSPITAL . SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    H10: THE ACTUAL DEVICE WAS NOT AVAILABLE; HOWEVER, A PHOTOGRAPH OF THE SAMPLE WAS PROVIDED FOR EVALUATION. THE PHOTOGRAPH WAS VISUALLY INSPECTED AND A CRACKED MAIN BODY WAS OBSERVED. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CRACKED MAIN BODY COULD NOT BE DETERMINED; THE DAMAGE WAS 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 CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    H10: ONE ACTUAL SAMPLE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION WITH THE NAKED EYE NOTED A DAMAGED/CRACKED MAIN BODY OF THE TWIST CLAMP AND BROKEN OCCLUDER LEGS. THE SAMPLE FAILED TO MEET SPECIFICATION. THE REPORTED CONDITION WAS VERIFIED. THE DAMAGE CRACKED/BROKEN 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A CRACK IN THE LIGHT BLUE MAIN BODY OF THE TWIST CLAMP ON A MINICAP EXTENDED LIFE PD TRANSFER SET. THIS OCCURRED 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
    782884 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA H21E04030 00085412007731

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown