BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 11261424 · Received February 1, 2021

    Report

    Report Number
    1416980-2021-00296
    Event Type
    Malfunction
    Date Received
    February 1, 2021
    Report Date
    March 4, 2021
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    PMA / PMN Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: THE DEVICE RECEIVED HAS A D4: CATALOGUE # OF 5C4482 AND ASSOCIATED WITH A G4: PMA/510K # OF K152675. H10: A DEVICE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION PERFORMED NOTED A HOLE IN THE TUBING NEAR THE OCCLUDE FEET ON THE MAIN BODY. FUNCTIONAL TESTING INCLUDING CLEAR PASSAGE AND CLAMP FUNCTION TESTING WERE PERFORMED WITH NO ISSUES NOTED. LEAK TESTING REVEALED A LEAK FROM THE HOLE IN THE SILICONE TUBING NEAR THE OCCLUDE FEET. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE HOLE COULD NOT BE DETERMINED. 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 THE TWIST CLAMP OF A MINICAP TRANSFER SET LEAKED; FURTHER DESCRIBED AS ¿LEAKING UNDERNEATH THE TWIST CLAMP DOWN THE TUBING¿. THIS WAS OBSERVED DURING USE OF PERITONEAL DIALYSIS THERAPY. THE TRANSFER SET WAS REPLACED. THERE WAS NO PATIENT INJURY, HOWEVER THE PATIENT RECEIVED ANTIBIOTIC TREATMENT AS A PRECAUTIONARY MEASURE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159035 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 NI.