BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NI

    MDR report key: 11333800 · Received February 16, 2021

    Report

    Report Number
    1416980-2021-00673
    Event Type
    Malfunction
    Date Received
    February 16, 2021
    Date of Event
    January 24, 2021
    Report Date
    March 22, 2021
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    PMA / PMN Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D10 (UPDATE FROM UNSPECIFIED TO KNOWN DEVICES), H3, H6. THE SAMPLE RECEIVED WAS IDENTIFIED AS - D1 BRAND NAME: MINICAP TRANSFER SET, D4 CATALOGUE #: 5C4482, G4 510K #: K152675. H10: ONE ACTUAL SAMPLE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION WITH THE NAKED EYE NOTED THE FEMALE CONNECTOR SEPARATED FROM THE MAIN BODY THERE WAS EVIDENCE THE INSERT CHIP WAS PRESENT AND POSSIBLY DISLODGED DURING THE SEPARATION. THERE WAS NO SOLVENT PRESENT ON THE MAIN BODY OF THE TRANSFER SET. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION IS RELATED TO INADEQUATE SOLVENT APPLICATION DURING MANUFACTURING. 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

    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 FEMALE CONNECTOR (DARK BLUE) SEPARATED FROM THE MAIN BODY OF A TRANSFER SET. THIS ISSUE OCCURRED DURING USE. 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
    228594 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 AMIA CASSETTE| AMIA DEVICE| UNSPECIFIED CASSETTE| UNSPECIFIED CYCLER