BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PI PICC KIT: 1-L 4 FR X 50 CM WITH PRELO

    MDR report key: 10158525 · Received June 16, 2020

    Report

    Report Number
    1036844-2020-00188
    Event Type
    Malfunction
    Date Received
    June 16, 2020
    Date of Event
    May 29, 2020
    Report Date
    June 8, 2020
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    LJS
    PMA / PMN Number
    K121941
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    QN#(B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND NO RELEVANT FINDINGS WERE IDENTIFIED. WITHOUT THE DEVICE TO EVALUATE THE COMPLAINT COULD NOT BE CONFIRMED AND THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE. IF THE SAMPLE BECOMES AVAILABLE AT A LATER DATE A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS.

    Additional Manufacturer Narrative · 0

    (B)(4). CORRECTED DATA: SECTION D.1.-BRAND NAME CORRECTED TO PI PICC KIT: 1-L 4 FR X 50 CM WITH PRELO. SECTION D.4.-PRODUCT CODE CORRECTED TO CDC-35041-VPS. THE CUSTOMER RETURNED ONE PEEL-AWAY SHEATH/DILATOR ASSEMBLY FOR ANALYSIS. SIGNS-OF-USE IN THE FORM OF BIOLOGICAL MATERIAL WAS OBSERVED ON THE DILATOR BODY. VISUAL ANALYSIS REVEALED THAT THE SHEATH TIP WAS FRAYED AND SLIGHTLY FOLDED OUTWARD. THIS DEFECT IS CONSISTENT WITH DAMAGE DUE TO UNDUE FORCE APPLIED DURING INSERTION. THE PEEL-AWAY TOTAL LENGTH FROM THE TABS TO THE TIP MEASURED 2 3/4", WHICH IS WITHIN THE SPECIFICATION LIMITS OF 2 5/8"-2 7/8" PER THE PEEL-AWAY GRAPHIC. THE PEEL-AWAY OUTER DIAMETER MEASURED .077", WHICH IS WITHIN THE SPECIFICATION LIMITS OF .075"-.081" PER THE PEEL-AWAY EXTRUSION GRAPHIC. THE PEEL-AWAY INNER DIAMETER AT THE DISTAL TIP MEASURED .061", WHICH IS WITHIN THE SPECIFICATION LIMITS OF .060"-.061" PER THE PEEL-AWAY GRAPHIC. THE DILATOR WAS ABLE TO BE INSERTED AND REMOVED WITH LITTLE TO NO DIFFICULTY. THE TABS ON THE PEEL-AWAY CATHETER WERE BROKEN AND PULLED APART TO SEE IF IT WOULD TEAR CORRECTLY. THE PEEL-AWAY TORE ALL THE WAY DOWN THE EXTRUSION, AND WAS ALONG THE SCORE LINE. NO DEFECTS OR ANOMALIES WERE OBSERVED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. THE IFU PROVIDED WITH THE KIT INFORMS THE USER, "DO NOT WITHDRAW TISSUE DILATOR UNTIL THE SHEATH IS WELL WITHIN VESSEL TO REDUCE THE RISK OF DAMAGE TO SHEATH TIP". THE REPORT THAT THE PEEL-AWAY SPLIT PREMATURELY WAS CONFIRMED THROUGH COMPLAINT INVESTIGATION OF THE RETURNED SAMPLE. VISUAL ANALYSIS REVEALED THE SHEATH TIP WAS FRAYED AND SLIGHTLY FOLDED OUTWARD. DESPITE THIS, THE PEEL-AWAY MET ALL RELEVANT DIMENSIONAL AND FUNCTIONAL REQUIREMENTS, AND A DEVICE HISTORY RECORD REVIEW WAS PERFORMED WITH NO RELEVANT FINDINGS. BASED ON THE CUSTOMER REPORT AND THE SAMPLE RECEIVED, UNINTENTIONAL USER ERROR LIKELY CAUSED OR CONTRIBUTED TO THIS EVENT. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTS THAT THE PEEL-AWAY SHEATHS PEEL BACK WHEN ATTEMPTING TO PLACE OVER GUIDEWIRE/THROUGH SKIN AND INTO VEIN.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTS THAT THE PEEL-AWAY SHEATHS PEEL BACK WHEN ATTEMPTING TO PLACE OVER GUIDEWIRE/THROUGH SKIN AND INTO VEIN.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT THE PEEL-AWAY SHEATHS PEEL BACK WHEN ATTEMPTING TO PLACE OVER GUIDEWIRE/THROUGH SKIN AND INTO VEIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621688 PI PICC KIT: 1-L 4 FR X 50 CM WITH PRELO CATHETER, INTRAVASCULAR, THER LJS ARROW INTERNATIONAL INC. 23F19L0461

    Patients

    Seq Age Sex Outcome Treatment
    1