BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PICC SET: 4 FR X 19-5/8" (50 CM)

    MDR report key: 5618574 · Received April 28, 2016

    Report

    Report Number
    9680794-2016-00064
    Event Type
    Malfunction
    Date Received
    April 28, 2016
    Date of Event
    April 12, 2016
    Report Date
    April 20, 2016
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    LJS
    PMA / PMN Number
    K073451
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QN#(B)(4). DEVICE EVALUATION: THE REPORT THAT THE CATHETER BODY RUPTURED DURING USE WAS CONFIRMED. ONE ARROW 4 FR SINGLE-LUMEN CATHETER WAS RETURNED. VISUAL EXAMINATION FOUND THAT THE BODY OF THE CATHETER IS RUPTURED JUST BELOW THE JUNCTURE HUB AT THE 50 CM MARK. THE RUPTURE MEASURED APPROXIMATELY 5 MM IN LENGTH (GA-LN-0560-001). THE EXTRUSION GRAPHIC LISTS THE OUTSIDE DIAMETER OF THE CATHETER BODY AT .054/.057 INCHES AND THE INSIDE DIAMETER AT .032/.035 INCHES. USING PIN GAGES, THE ID WAS MEASURED AT .034 INCHES. THE OD MEASURED .056 INCHES. THESE MEASUREMENTS INDICATE THAT THE WALL THICKNESS OF THE CATHETER BODY WAS ADEQUATE. THE INSTRUCTION BOOKLET CONTAINS WARNINGS AND PRECAUTIONS TO PREVENT CATHETER RUPTURE. THE IFU WARNS NOT TO EXCEED THE MAXIMUM PRESSURE OF 300 PSI AND NOT TO EXCEED 5 INJECTIONS OR THE CATHETERS MAXIMUM RECOMMENDED FLOW RATE. THE LIDSTOCK GRAPHIC SPECIFIES A MAXIMUM FLOW RATE OF 720 ML/HR. THE IFU INSTRUCTS THE USER TO WARM CONTRAST TO BODY TEMPERATURE PRIOR TO POWER INJECTION AND THAT PRESSURE LIMIT SETTINGS MAY NOT PREVENT OVER PRESSURIZATION OF AN OCCLUDED CATHETER. OTHER REMARKS: THE INSTRUCTION BOOKLET ALSO STATES TO USE APPROPRIATELY RATED 60 INCH PRESSURE TUBING BETWEEN THE CATHETER AND POWER INJECTOR EQUIPMENT TO MINIMIZE THE RISK OF CATHETER FAILURE. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND DID NOT REVEAL ANY MANUFACTURING RELATED ISSUES. BASED ON THE INFORMATION REPORTED, DAMAGE OBSERVED, AND ID/OD MEASUREMENTS OF THE CATHETER BODY, OPERATIONAL CONTEXT CAUSED OR CONTRIBUTED TO THIS EVENT. NO FURTHER ACTION WILL BE TAKEN.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SINGLE LUMEN PICC PLACED IN THE PATIENT'S RIGHT BASILIC VEIN WAS CONNECTED TO THE CONTRAST INJECTOR. LINE STATES 4ML/SEC PRESSURE FOR CTCA SCAN. THE PRESSURE WAS SET AT 3.9ML/SEC, SCAN COMMENCED AND COMPLETED. MAXIMUM PSI/THRESHOLD WAS NOT REACHED. ON COMPLETION OF THE SCAN, BLEEDING WAS NOTED FROM PICC APPROXIMATELY 1CM FROM THE HUB. ON EXAMINATION, IT WAS NOTED THAT THE LINE HAD RUPTURED. AS A RESULT, THE PICC REMOVED, HOWEVER NOT REPLACED AS THE PROCEDURE WAS COMPLETE. THERE WAS NO REPORTED DELAY, DEATH, OR COMPLICATIONS TO THE PATIENT AS A RESULT OF THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270322 PICC SET: 4 FR X 19-5/8" (50 CM) PERIPHERALLY INSERTED CATHETER PRODU LJS ARROW INTERNATIONAL INC. 14F15J0264

    Patients

    Seq Age Sex Outcome Treatment
    1