BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 11558881 · Received March 23, 2021

    Report

    Report Number
    1416980-2021-01559
    Event Type
    Malfunction
    Date Received
    March 23, 2021
    Date of Event
    February 26, 2021
    Report Date
    April 27, 2021
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    PMA / PMN Number
    K152675
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D1, D4, D9, G5, H3, H6. D1 BRAND NAME: UPDATED TO MINICAP TRANSFER SET. D4 CATALOGUE #: FROM ASKU TO 5C4482. G5 PMA/510K #: FROM NI TO K152675. H10: THE SAMPLE WAS RECEIVED FOR EVALUATION ATTACHED TO A PATIENT CONNECTOR. A VISUAL INSPECTION WITH THE NAKED EYE AND MAGNIFICATION NOTED THE FEMALE CONNECTOR SEPARATED FROM THE MAIN BODY. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION WAS RELATED TO INADEQUATE SOLVENT APPLICATION TO THE MAIN BODY DURING THE MANUFACTURING PROCESS. A NONCONFORMANCE HAS BEEN OPENED TO ADDRESS THIS ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER ADDRESS: (B)(6). 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 FEMALE CONNECTOR AND THE MAIN BODY OF A PERITONEAL DIALYSIS (PD) TRANSFER SET. THIS OCCURRED DURING USE OF THE DEVICE FOR PERITONEAL DIALYSIS THERAPY. TO RESOLVE THIS ISSUE, THE TRANSFER SET WAS REPLACED. 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
    455134 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1