BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING TITANIUM ADAPTER

    MDR report key: 18889042 · Received March 12, 2024

    Report

    Report Number
    1416980-2024-01088
    Event Type
    Malfunction
    Date Received
    March 12, 2024
    Date of Event
    February 18, 2024
    Report Date
    April 19, 2024
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B5: REMOVE STATEMENT ¿NON-BAXTER PRODUCT¿. D1: BRAND NAME: TITANIUM TRANSFER SET (REMOVE AND CHANGE TO LOCKING TITANIUM ADAPTER). D4: CATALOGUE #: T5C4326K (REMOVE AND CHANGE TO ATC4510). D4: LOT #: ASKU (REMOVE AND CHANGE TO K21021). D10: CONCOMITANT PRODUCT: KANAE TITANIUM ADAPTER (REMOVE AND CHANGE TO TITANIUM TRANSFER SET). G1: DEVICE MANUFACTURER NAME: BAXTER HEALTHCARE - MOUNTAIN HOME (REMOVE AND CHANGE TO KANAE CO., LTD. EHIME DAIICHI FACTORY. G1: DEVICE MANUFACTURER ADDRESS 1: 1900 N HIGHWAY 201 (REMOVE AND REPLACE WITH SEE H10 OF INITIAL MDR). G1: DEVICE MANUFACTUER CITY: MOUNTAIN HOME (REMOVE AND REPLACE WITH SHIKOKUCHUO EHIME). G1: DEVICE MANUFACTURER STATE: AR (REMOVE AND UPDATE TO NA). G1: DEVICE MANUFACTURER POSTAL CODE: 72653 (REMOVE AND CHANGE TO 799-0112). G1: DEVICE MANUFACTURER POSTAL CODE - 799-0112. H6: HEALTH EFFECT ¿ IMPACT CODES: F27 (REMOVE AND CHANGE TO F26). H6: MEDICAL DEVICE PROBLEM CODES: A0414 (REMOVE). H6: COMPONENT CODES: REMOVE G04034 AND G04134. B5: IT WAS REPORTED THE CUT IN THE TUBING OF THE TRANSFER SET WAS RELATED TO THE TITANIUM ADAPTER. H10: THE ACTUAL SAMPLE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED AND THERE WERE NO SCRATCHES, FOREIGN OBJECTS, OR OTHER ABNORMALITIES THAT COULD LEAD TO THE REPORTED CONDITION. A DIMENSION INSPECTION AND A CONNECTION TEST WAS PERFORMED WITH NO ISSUES NOTED. THE DEVICE MET SPECIFICATIONS. THE REPORTED CONDITION WAS NOT VERIFIED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    G1: DEVICE MANUFACTURER ADDRESS 1: (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TUBE OF A TITANIUM TRANSFER SET AND A NON-BAXTER TITANIUM ADAPTER ¿HAVE COME OFF¿ AND THERE WAS ALSO A CUT IN THE TRANSFER SET TUBING. THIS WAS OBSERVED DURING AN UNSPECIFIED PROCESS STEP FOR PERITONEAL DIALYSIS THERAPY. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    717140 LOCKING TITANIUM ADAPTER SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA K21021

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown KANAE TITANIUM ADAPTER| TITANIUM TRANSFER SET