BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE LUMEN PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET

    MDR report key: 3011056 · Received March 13, 2013

    Report

    Report Number
    1820334-2013-00123
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    February 7, 2013
    Report Date
    February 18, 2013
    Manufacturer
    COOK, INC.
    Product Code
    DQY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - NOT LISTED IN THE INSTRUCTIONS FOR USE. (B)(4) - SEPARATES IS LISTED IN THE INSTRUCTIONS FOR USE. ADDITIONAL INFO: THE PRODUCT WAS RETURNED IN AN OPENED AND USED CONDITION. UPON VISUAL INSPECTION IT WAS NOTED THAT THE CATHETER HAD SEPARATED FROM THE TIP. QUALITY CONTROL CONFIRMS OVERALL CATHETER ASSEMBLY IS CLEAN AND SMOOTH PRIOR TO SHIPPING. THIS PRODUCT IS SHIPPED WITH INSTRUCTIONS FOR USE WHICH STATES UNDER WARNINGS: "SILICONE PERIPHERALLY INSERTED CENTRAL VENOUS CATHETERS (PICC) ARE NOT DESIGNED FOR POWER INJECTION OF CONTRAST MATERIAL. DO NOT POWER INJECT CONTRAST MEDIUM THROUGH CATHETER. CATHETER RUPTURE MAY RESULT. USE OF 10 CC SYRINGE OR LARGER WILL REDUCE THE RISK OF CATHETER RUPTURE." THE COMPLAINT STATED THAT THE PT WAS TAKEN TO HAVE AN MRI AND CONTRAST WAS USED. NOT FOLLOWING THE INSTRUCTIONS FOR USE COULD HAVE LED TO THIS FAILURE MODE. THE APPROPRIATE INTERNAL PERSONNEL HAVE BEEN NOTIFIED AND WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    PT HAD PICC LINE IN FOR TREATMENT OF AN INFECTION POST FRACTURED ARM. PT WAS TAKEN TO MRI AND SCAN WAS PERFORMED USING CONTRAST. POST MRI SCAN, PICC WAS UNABLE TO BE FLUSHED AND WAS NO LONGER PT AND NEEDED TO BE REMOVED. DURING REMOVAL, THE TIP OF PICC LINE WAS FOUND TO BE BROKEN. PT TAKEN TO CATH LAB. TIP FOUND IN PT'S RIGHT ATRIUM AND REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106366 SINGLE LUMEN PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET DQY CATHETER, PERCUTANEOUS DQY COOK, INC. NA 3859042

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Required Intervention