BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 15898731 · Received December 1, 2022

    Report

    Report Number
    1416980-2022-06583
    Event Type
    Malfunction
    Date Received
    December 1, 2022
    Date of Event
    November 7, 2022
    Report Date
    January 12, 2023
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    PMA / PMN Number
    K152675
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER ADDRESS: (B)(6). THE DEVICE WAS RECEIVED AND IS CURRENTLY AWAITING EVALUATION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTION TO D4: CATALOGUE #: CHANGED FROM 5C4483 TO 5C4482. ADDITIONAL INFORMATION ADDED TO G4: PMA/510K # OR BLA #: K152675. H10: SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER RETURNED A SAMPLE WITH PRODUCT CODE 5C4482 FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED WITH NAKED EYE WITH NO ISSUES NOTED. FUNCTIONAL TESTING INCLUDING LEAK, CLEAR PASSAGE, AND CLAMP FUNCTION TESTING WERE PERFORMED WITH NO ISSUES NOTED. THE REPORTED CONDITION WAS NOT VERIFIED. 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 LEAK BETWEEN THE CONNECTION OF THE MINICAP TRANSFER SET AND A TITANIUM ADAPTER. THIS WAS OBSERVED DURING USE OF THE DEVICES FOR PERITONEAL DIALYSIS (PD) THERAPY. THERE WERE NO ISSUES WITH THE TITANIUM ADAPTER; THEREFORE THE TITANIUM ADAPTER REMAINED IN USE. THE TRANSFER SET WAS REPLACED. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT, HOWEVER THE PATIENT WAS GIVEN PROPHYLACTIC ANTIBIOTICS AS PRECAUTIONARY MEASURE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2574812 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown TITANIUM ADAPTER