BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 14338701 · Received May 9, 2022

    Report

    Report Number
    1416980-2022-02324
    Event Type
    Malfunction
    Date Received
    May 9, 2022
    Date of Event
    April 14, 2022
    Report Date
    July 8, 2022
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    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

    ADDITIONAL INFORMATION IN D9, H3, H6 AND H10. H10: THE DEVICE WAS RECEIVED FOR EVALUATION WITH A MINICAP ON THE DARK BLUE CONNECTOR AND THE WHITE TWIST CLAMP IN THE CLOSED POSITION. A VISUAL INSPECTION WITH THE NAKED EYE AND MAGNIFICATION REVEALED A CRACKED LIGHT BLUE MAIN BODY. 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 AND A CRACKED LIGHT BLUE 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. 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 FOUR (4) TRANSFER SETS. 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
    1823261 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown