BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIDLINE CATHETERIZATION KIT: 4 FR X 8"

    MDR report key: 5585253 · Received April 18, 2016

    Report

    Report Number
    1036844-2016-00219
    Event Type
    Malfunction
    Date Received
    April 18, 2016
    Date of Event
    April 11, 2016
    Report Date
    April 12, 2016
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    LJS
    PMA / PMN Number
    K963257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE REPORT THAT THE BODY OF THE MIDLINE CATHETER FRACTURED BETWEEN THE 2-4 CM MARK COULD NOT BE CONFIRMED. ONE ARROW SINGLE-LUMEN 4 FR CATHETER WAS RETURNED. THE CATHETER WAS VISUALLY EXAMINED. THE DISTAL 6 CM OF THE CATHETER BODY WAS FOUND TO BE MISSING. THE JAGGED APPEARANCE ON THE END OF THE CATHETER BODY INDICATES THAT THE BODY WAS TORN. ADDITIONALLY, THE CATHETER BODY WAS SEPARATED BETWEEN THE 18 AND 19 CM MARKS. THE ENDS OF THE BODY AT THE SEPARATION WERE SMOOTH INDICATING THAT THE CATHETER HAD BEEN CUT. THE CATHETER BODY EXTRUSION GRAPHIC SPECIFIES THE INSIDE DIAMETER AT .032/.035 INCHES AND THE OUTSIDE DIAMETER AT .054/.057 INCHES. USING PIN GAGES THE ID WAS MEASURED AT .034 INCHES AND THE OUTSIDE DIAMETER WAS MEASURED AT .056 INCHES. BASED ON THESE MEASUREMENTS, THE WALL THICKNESS OF THE EXTRUSION APPEARS TO BE ADEQUATE. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND DID NOT REVEAL ANY MANUFACTURING RELATED ISSUES. THE PROBABLE CAUSE OF THIS ISSUE COULD NOT BE DETERMINED BASED ON THE INFORMATION PROVIDED AND WITHOUT A COMPLETE SAMPLE. NO FURTHER ACTION WILL BE TAKEN.

    Description of Event or Problem · 1

    IT WAS REPORTED THE MIDLINE CATHETER WAS BEING USED IN A PATIENT WITH CONTRACTURES AND A PICC COULD NOT BE PLACED. THERE WERE NO ISSUES PLACING THE MIDLINE. APPROXIMATELY 24-36 HOURS AFTER PLACEMENT, IT WAS NOTED TO BE LEAKING FROM THE INSERTION SITE. UPON INVESTIGATION, THEY DETERMINED THE MIDLINE HAD FRACTURED BETWEEN THE 2-4CM MARK. AS A RESULT, THE CATHETER WAS REMOVED AND ANOTHER MIDLINE CATHETER WAS PLACED FOR THE PATIENT. THERE WAS NO PATIENT DEATH OR COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239729 MIDLINE CATHETERIZATION KIT: 4 FR X 8" PERIPHERAL CATHETER PRODUCTS LJS ARROW INTERNATIONAL INC. 23F15G1157

    Patients

    Seq Age Sex Outcome Treatment
    1