BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 11120649 · Received January 5, 2021

    Report

    Report Number
    1416980-2020-08328
    Event Type
    Malfunction
    Date Received
    January 5, 2021
    Report Date
    February 24, 2021
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    PMA / PMN Number
    K192705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: H6. REPLACE 114 WITH C1601; REPLACE 4315 WITH D0301. H10: THE CAUSE OF THE CONDITION WAS DETERMINED, TO BE INADEQUATE SOLVENT APPLICATION, DURING THE MANUFACTURING PROCESS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    H10: THE DEVICE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED, AND IT WAS NOTED, THAT THE FEMALE CONNECTOR WAS SEPARATED FROM THE MAIN BODY. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE REPORTED CONDITION COULD NOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION/CORRECTION: D1:, D4: CATALOGUE # AND G5: PMA/510K # (OMITTED ON FOLLOW UP #1). D1: BRAND NAME IS MINICAP TRANSFER SET; D4: CATALOGUE # IS 5C4483; G5: PMA/510K # IS K192705. H10: FUNCTIONAL TESTING INCLUDING LEAK, CLEAR PASSAGE AND CLAMP FUNCTION TESTING WERE ALSO PERFORMED, WITH NO ISSUES NOTED. THE INSERT/CHIP WAS NOT PRESENT ON THE FEMALE CONNECTOR, BUT THERE WAS EVIDENCE THAT ONE WAS PRESENT. THERE WAS EVIDENCE OF SOLVENT INSIDE THE BARREL OF THE LIGHT BLUE MAIN BODY COMPONENT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED AND IS CURRENTLY AWAITING EVALUATION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A SEPARATION BETWEEN THE DARK BLUE CAP (FEMALE CONNECTOR) AND THE LIGHT BLUE PORTION (MAIN BODY) OF A PERITONEAL DIALYSIS (PD) TRANSFER SET. THIS WAS OBSERVED 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
    12752 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1