BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CG+ PICC/DELTA KIT: 1-L 4.5 FR X 55 CM

    MDR report key: 5976101 · Received September 25, 2016

    Report

    Report Number
    1036844-2016-00510
    Event Type
    Malfunction
    Date Received
    September 25, 2016
    Date of Event
    September 1, 2016
    Report Date
    September 1, 2016
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    LJS
    PMA / PMN Number
    K122545
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE REPORT THAT THE SHEATH TIP PEELED BACK DURING INSERTION WAS CONFIRMED. RETURNED WAS A PEEL-AWAY SHEATH/DILATOR COMBINATION. WITH THE UNAIDED EYE, THE SHEATH TIP APPEARED DAMAGED AND IT HAD STARTED TO SPLIT ALONG THE SCORE LINES. THE DILATOR BODY WAS BENT SLIGHTLY, BUT THE TIP OF THE DILATOR DID NOT APPEAR DAMAGED. UNDER MICROSCOPIC EXAMINATION, THE VERY TIP OF THE SHEATH HAD MULTIPLE SPLITS AND WAS SLIGHTLY FOLDED BACK IN SOME AREAS. THE SHEATH BODY MEASURED 2.86" IN LENGTH, WHICH MEETS SPECIFICATION OF 2.625 - 2.875" PER THE SHEATH GRAPHIC. THE SHEATH TIP INSIDE DIAMETER (ID) COULD NOT BE MEASURED DUE TO THE TIP SPLITTING. THE OUTSIDE DIAMETER (OD) OF THE DILATOR BODY MEASURED 0.064" USING RING GAUGES, WHICH MEETS THE .061 - .065" REQUIREMENT OF THE DILATOR EXTRUSION GRAPHIC. THE DILATOR PROTRUDED THROUGH THE CATHETER 0.688", WHICH MEETS THE SPECIFICATION OF 0.500 - 1.000" PER THE SHEATH/DILATOR ASSEMBLY GRAPHIC. 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. FURTHER INVESTIGATION OF THIS COMPLAINT ISSUE IS BEING CONDUCTED.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING INSERTION THE SHEATH PEELED BACK. AS A RESULT, A SECOND SHEATH WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT DEATH OR COMPLICATIONS REPORTED. FOLLOW UP INFORMATION STATES A SKIN NICK WAS PERFORMED PRIOR TO INSERTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627520 CG+ PICC/DELTA KIT: 1-L 4.5 FR X 55 CM ARROWG+ARD CATHETER PRODUCTS LJS ARROW INTERNATIONAL INC. 23F16E0548

    Patients

    Seq Age Sex Outcome Treatment
    1