BEUDAMED
    FDA Adverse Event Other Summary report: N

    V-CATH 2FR PICC

    MDR report key: 1908519 · Received November 23, 2010

    Report

    Report Number
    2925153-2010-00016
    Event Type
    Other
    Date Received
    November 23, 2010
    Date of Event
    October 12, 2010
    Report Date
    November 5, 2010
    Manufacturer
    NEO MEDICAL, INC.
    Product Code
    DQY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    FIRST RPTR: 25CM OR 40CM PICC, PRE-CUT TO 18CM, INSERTED EASILY. X-RAY SHOWED IT WAS COILED AND IT WAS PULLED AND DISCARDED. A 2ND ATTEMPT PICC WOULD ONLY GO IN A FEW CMS. (B)(6) A SAPHENOUS LINE WAS PLACED. (B)(6) A CHEST X-RAY SHOWED A PIECE IN THE HEART. SURGERY PERFORMED AND 11.2CM PIECE WAS REMOVED FROM THE BABY'S HEART. SECOND RPTR: NICU PICC RN PREPARED TO INSERT A 2.0 FR V-CATH PICC INTO AN NICU PT. AFTER THE BABY'S MEASUREMENTS WERE ASSESSED THE LINE WAS TRIMMED USING A SCALPEL TO 18CM. THE PICC RN REPORTS THAT THE LINE WAS EASY TO INSERT AND THAT, AFTER INSERTION, THE LINE WAS BOTH EASY TO FLUSH AND EASY TO WITHDRAW BLOOD. UNFORTUNATELY, THIS PICC HAD TO BE REMOVED 2 HRS AFTER INSERTION BECAUSE THE CXR THAT WAS DONE TO CONFIRM THE LINE POSITION IDENTIFIED THAT THE LINE WAS COILED. THE LINE WAS IMMEDIATELY REMOVED AND DISCARDED WITHOUT INCIDENT BY THE PICC RN AND A 2ND V-CATH PICC INSERTION WAS ATTEMPTED THROUGH THE SAME INTRODUCER/SITE AS THE 1ST. THE SECOND LINE COULD NOT BE ADVANCED PAST A FEW CMS AND SO IT WAS ALSO REMOVED AND NO FURTHER ATTEMPTS WERE MADE AT THAT TIME. ON (B)(6), AFTER A CXR WAS DONE IT WAS NOTED THAT THERE WAS A PIECE OF A CATHETER LODGED IN THE BABY'S HEART. ON (B)(6), THE BABY WAS TAKEN TO CARDIAC CATH LAB FOR REMOVAL OF THE CATHETER REMNANT. THE CARDIOLOGIST WAS SUCCESSFUL TO REMOVE THE 11.2CM PIECE OF PICC CATHETER FROM THE HEART WITHOUT ANY HARM COMING TO THE PT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V-CATH 2FR PICC LONG-TERM INTRAVASCULAR CATHETER DQY NEO MEDICAL, INC. 355-70 OR 355-72

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention