BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 18312416 · Received December 12, 2023

    Report

    Report Number
    1416980-2023-06468
    Event Type
    Malfunction
    Date Received
    December 12, 2023
    Report Date
    January 17, 2024
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    UDI-DI
    00085412007748
    PMA / PMN Number
    K192705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    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

    CORRECTION MADE TO B5: CHANGE QUANTITY OF UNITS REPORTED TO AN UNSPECIFIED QUANTITY OF MINICAP TRANSFER SETS (PREVIOUSLY REPORTED AS ONE UNIT). CORRECTION MADE TO G3: DATE RECEIVED BY MFR: 11/17/2023 (PREVIOUSLY SUBMITTED AS 11/16/2023). CORRECTION MADE TO G4: PMA/510K # OR BLA #: K192705 (PREVIOUSLY SUBMITTED AS NI). ADDITIONAL INFORMATION WAS ADDED TO B3/D10, H3, H6 AND H10. B3/D10: THE EVENTS OCCURRED ON AN UNSPECIFIED DATE IN 2023, REPORTED AS "IN THE LAST FEW WEEKS." H10: THE ACTUAL DEVICES WERE NOT AVAILABLE; HOWEVER FOUR (4) PHOTOGRAPHS OF THE SAMPLES WERE PROVIDED FOR EVALUATION. THE PHOTOGRAPHS WERE VISUALLY INSPECTED AND A SEPARATION BETWEEN THE TWIST CLAMP AND MAIN BODY WAS OBSERVED. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE SEPARATION WAS DUE TO BROKEN OCCLUDER LEGS BENEATH THE TWIST CLAMP. THE CAUSE OF THE BROKEN OCCLUDE LEGS COULD NOT BE DETERMINED, HOWEVER EXPOSURE TO CHEMICAL AGENTS SUCH AS HYDROGEN PEROXIDE, ALCOHOL OR BLEACH AS LISTED ON PRODUCT PACKAGING CAN DAMAGE THE TRANSFER SET MATERIALS. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A SEPARATION BETWEEN THE WHITE TWIST SLEEVE AND THE LIGHT BLUE MAIN BODY OF THE MINICAP TRANSFER SET. THIS OCCURRED DURING AN UNSPECIFIED PROCESS STEP OF 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
    1111356 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA H22I22058 00085412007748

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown