BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BROVIAC 2.7 FR SL CVC CUTDOWN TRAY W/SURECUFF TISSUE

    MDR report key: 3810168 · Received April 29, 2014

    Report

    Report Number
    3006260740-2014-00218
    Event Type
    Injury
    Date Received
    April 29, 2014
    Date of Event
    January 29, 2014
    Report Date
    April 11, 2014
    Manufacturer
    C.R. NARD, INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K830256
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION, AS THE DEVICE IS BEING RESTRAINED BY THE REPORTING FACILITY. A LOT HISTORY REVIEW (LHR) OF REWG1464 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    UPON REMOVING THE SUTURE HOLDING THE CATHETER IN POSITION, THE HUB AND SHORT CATHETER PIECE WERE EASILY REMOVED BUT THE LENGTH OF THE CATHETER REMAINED IN THE VEIN. THE VEIN WAS EXPLORED AND THE CATHETER REMOVED AND SENT TO PATHOLOGY. (B)(6) 2014. ADD'L INFO RECEIVED: BREAK IN THE CATHETER 1-2 CM DISTAL TO THE EXIT SITE DURING REMOVAL. THE TIP OF THE RESIDUAL CATHETER WAS LOCATED UNDER FLUOROSCOPY AND FOUND RELATIVELY HIGH IN THE GROIN. A SAPHENOUS VENOTOMY WAS PERFORMED AND THE CATHETER WAS REMOVED. NO LONG TERM PT INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256492 BROVIAC 2.7 FR SL CVC CUTDOWN TRAY W/SURECUFF TISSUE LJS C.R. NARD, INC. (BASD) REWG1462

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention