BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HICKMAN 9 FR DL CVC, PEEL-APART INTRODUCER KIT W/SURE CUFF

    MDR report key: 3121689 · Received May 6, 2013

    Report

    Report Number
    3006260740-2013-00207
    Event Type
    Injury
    Date Received
    May 6, 2013
    Date of Event
    December 12, 2012
    Report Date
    May 1, 2013
    Manufacturer
    C. R. BARD INC.
    Product Code
    LJS
    PMA / PMN Number
    K830233
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MFR FOR EVAL. A LOT HISTORY REVIEW (LHR) OF HUWB0973 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    A DOUBLE LUMEN CENTRAL VENOUS CATHETER WAS PLACED IN THE RIGHT INTERNAL JUGULAR VEIN UNDER FLUOROSCOPY GUIDANCE. THE TIP PLACEMENT WAS CONFIRMED WITH CHEST X-RAY POST PROCEDURE AND BOTH LINES HAD A GOOD RETURN WITH FLUSHING AFTER PLACEMENT. CHEMOTHERAPY WAS ADMINISTERED VIA THE PORT. THE PATIENT COMPLAINED OF PAIN AT THE CATHETER SITE AND HAD INCREASING COMPLAINTS OF SHORTNESS OF BREATH. LAB VALUES ON BLOOD DRAWN FROM THE LINE WERE ABNORMALLY LOW. FOLLOW UP CHEST X-RAY INDICATED THE LINE WAS IN THE PLEURAL SPACE AND THE PATIENT HAD A PLEURAL EFFUSION. THE PATIENT WAS ADMITTED TO ICU FOR MONITORING. A CHEST TUBE WAS PLACED FOR DRAIN AND IRRIGATED THE CHEMO FLUID. THE PATIENT WAS DISCHARGED TO HER HOME. THERE IS A CONCERN FOR REPEATED FLUID BUILD-UP IN THE PLEURAL SPACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197468 HICKMAN 9 FR DL CVC, PEEL-APART INTRODUCER KIT W/SURE CUFF LJS C. R. BARD INC. HUWB0973

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention DAUNORUBICIN 158 MG: IVBP OVER 30 MINUTES| CYTARABINE 175 MG: IVBP OVER 24 HOURS| CHEMOTHERAPY| LAST CHEMOTHERAPY