BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 11007084 · Received December 15, 2020

    Report

    Report Number
    1416980-2020-07763
    Event Type
    Malfunction
    Date Received
    December 15, 2020
    Report Date
    December 30, 2020
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    PMA / PMN Number
    K192705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION MADE TO G5: PMA/510K #: K192705 (PREVIOUSLY K152675). H10: A RECALL (FA-2020-055) IS ASSOCIATED WITH THE TWO SUSPECTED LOT NUMBERS (H20E19054 AND H20D30070) REPORTED BY THE CUSTOMER. THE DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    LOT #: TWO SUSPECTED LOT NUMBERS: H20E19054 AND H20D30070. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) TRANSFER SET WAS LEAKING FROM AN UNSPECIFIED LOCATION. THIS WAS NOTICED DURING AN UNSPECIFIED PROCESS STEP 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
    1472634 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 NI.| NI.