BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAREFUSION THORA/PARA 5F NON-VALVED CATHETER DRAINAGE T

    MDR report key: 8456815 · Received March 26, 2019

    Report

    Report Number
    MW5085212
    Event Type
    Injury
    Date Received
    March 26, 2019
    Date of Event
    March 20, 2019
    Report Date
    March 21, 2019
    Manufacturer
    CAREFUSION 2200, INC
    Product Code
    JOL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THORACENTESIS FOR PLEURAL EFFUSION. INDICATION: PLEURAL EFFUSION, REMOVAL OF FLUID FOR DIAGNOSTIC PURPOSES AND REMOVAL OF FLUID FOR THERAPEUTIC PURPOSES. COMPLICATIONS: THE CATHETER TIP BROKE OFF AND REMAINED IN THE PLEURAL SPACE. THE REST OF THE CATHETER WAS GIVEN TO THE PATIENT'S NURSE. PROCEDURE: THE PATIENT WAS PLACED IN THE RIGHT LATERAL RECUMBENT POSITION AND THE APPROPRIATE LANDMARKS WERE IDENTIFIED. THE SKIN OVER THE PUNCTURE SITE IN THE LEFT POSTERIOR CHEST WALL WAS PREPPED WITH CHLORHEXIDINE. LOCAL ANESTHESIA WAS OBTAINED BY INFILTRATION USING 1% LIDOCAINE WITHOUT EPINEPHRINE. A CATHETER WAS THEN ADVANCED INTO THE PLEURAL SPACE OVER A NEEDLE AND THE NEEDLE WAS WITHDRAWN. PLEURAL FLUID WAS RETURNED WHICH WAS SERIOUS. A TOTAL VOLUME OF 700 CC WAS WITHDRAWN WHICH WAS SENT TO THE LAB FOR CELL COUNT AND DIFFERENTIAL, PH, GLUCOSE, TOTAL PROTEIN, LDH, GRAM STAIN AND CULTURE AND CYTOLOGY. THE CATHETER WAS THEN WITHDRAWN AND A STERILE DRESSING WAS PLACED OVER THE SITE. A POST PROCEDURE FILM SHOWED A DECREASE IN THE SIZE OF EFFUSION. THE PATIENT TOLERATED THE PROCEDURE POORLY. IMMEDIATELY AFTER ENDING THE PROCEDURE, THE PATIENT HAD A VAGAL RESPONSE, BECAME BRADYCARDIC, AND APNEIC TRANSIENTLY FOR ABOUT 30 SECONDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243709 CAREFUSION THORA/PARA 5F NON-VALVED CATHETER DRAINAGE T THORACENTESIS KIT JOL CAREFUSION 2200, INC ? ?

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention