BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCKING TITANIUM ADAPTER FOR PERITONEAL DIALYSIS CATHETER

    MDR report key: 15462265 · Received September 22, 2022

    Report

    Report Number
    15462265
    Event Type
    Injury
    Date Received
    September 22, 2022
    Date of Event
    August 16, 2022
    Report Date
    September 9, 2022
    Manufacturer
    BAXTER INTERNATIONAL INC.
    Product Code
    KDJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    TWO CAPD PATIENTS WERE FOUND TO HAVE THEIR CONNECTION BETWEEN THEIR PD CATHETER TITANIUM ADAPTER/TRANSFER SET VERY LOOSE AND NO SYMPTOMS. PATIENT V. CATHETER TRANSFER TUBING FELL OFF ON [REDACT DATE], PATIENT REPORTED TO STAFF ON [REDACT DATE]. DATE OF PD CATHETER INSERTION [REDACT DATE]. PATIENT D. REPORTED TO STAFF [REDACT DATE] ABOUT TRANSFER TUBING DISCONNECT. PATIENT WAS UNSURE OF THE DATE TUBING DISCONNECT HAPPENED. PD CATHETER INSERTED IN OR ON [REDACT DATE]. THEY BOTH NOW ARE BEING TREATED FOR PERITONITIS. MANUFACTURER RESPONSE FOR SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE, LOCKING TITANIUM ADAPTER FOR PERITONEAL DIALYSIS CATHETER (PER SITE REPORTER) [REDACT DATE] REPORT INCIDENT TO REPRESENTATIVES FROM BAXTER. [REDACT DATE] BAXTER REFERENCE ¿ (B)(4) EMAIL COMMUNICATION FROM GLOBAL PRODUCT SURVEILLANCE, BAXTER INTERNATIONAL INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533612 LOCKING TITANIUM ADAPTER FOR PERITONEAL DIALYSIS CATHETER SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER INTERNATIONAL INC. 5C4129

    Patients

    Seq Age Sex Outcome Treatment
    1 22995 DA Male Other| R