BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW PI PICC: 2:L 5FR X 55CM W/ 80CM HYDRO NI

    MDR report key: 11076616 · Received December 28, 2020

    Report

    Report Number
    9680794-2020-00514
    Event Type
    Malfunction
    Date Received
    December 28, 2020
    Date of Event
    December 2, 2020
    Report Date
    December 2, 2020
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    LJS
    PMA / PMN Number
    K113277
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE CUSTOMER RETURNED ONE SHEATH/DILATOR ASSEMBLY FOR ANALYSIS. SIGNS-OF-USE IN THE FORM OF BIOLOGICAL MATERIAL WAS OBSERVED ON THE SHEATH TABS. THE CATHETER WAS NOT RETURNED FOR ANALYSIS. VISUAL ANALYSIS DID NOT REVEAL ANY DEFECTS OR ANOMALIES ON THE SHEATH BODY. VISUAL ANALYSIS COULD NOT BE PERFORMED ON THE CATHETER AS IT WAS NOT RETURNED FOR ANALYSIS. THE SHEATH BODY LENGTH FROM THE TABS TO THE TIP MEASURED 4 1/16", WHICH IS WITHIN THE SPECIFICATION LIMITS OF 3 7/8"-4 1/8" PER THE SHEATH GRAPHIC. THE SHEATH OUTER DIAMETER MEASURED .097", WHICH IS WITHIN THE SPECIFICATION LIMITS OF .093".099" PER THE SHEATH EXTRUSION GRAPHIC. THE SHEATH INNER DIAMETER AT THE PROXIMAL END MEASURED .076", WHICH IS WITHIN THE SPECIFICATION LIMITS OF .071"-.081" PER THE SHEATH EXTRUSION GRAPHIC. THE INNER DIAMETER AT THE SHEATH TIP MEASURED .074", WHICH IS WITHIN THE SPECIFICATION LIMITS OF .074"-.075" PER THE SHEATH GRAPHIC. A LAB INVENTORY 5FR PICC CATHETER WAS PASSED THROUGH THE RETURNED SHEATH. LITTLE TO NO RESISTANCE WAS OBSERVED AS THE CATHETER WAS ABLE TO PASS COMPLETELY THROUGH THE ASSEMBLY. THE RETURNED DILATOR WAS REMOVED AND REINSERTED BACK THROUGH THE SHEATH. LITTLE TO NO RESISTANCE WAS 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 USE EXCESSIVE FORCE WHEN INTRODUCING GUIDEWIRE, PEEL-AWAY SHEATH OVER TISSUE DILATOR OR TISSUE DILATOR AS THIS CAN LEAD TO VESSEL PERFORATION AND BLEEDING." THE REPORT OF A CATHETER TIGHT IN SHEATH COULD NOT BE CONFIRMED THROUGH COMPLAINT INVESTIGATION. VISUAL ANALYSIS OF THE RETURNED SHEATH/DILATOR ASSEMBLY DID NOT REVEAL ANY DEFECTS OR ANOMALIES. THE SHEATH MET ALL RELEVANT DIMENSIONAL AND FUNCTIONAL REQUIREMENTS, AND A DEVICE HISTORY RECORD REVIEW WAS PERFORMED WITH NO RELEVANT FINDINGS TO SUGGEST A MANUFACTURING RELATED ISSUE. BASED ON THE CUSTOMER REPORT AND THE SAMPLE RECEIVED, THE ROOT CAUSE CANNOT BE DETERMINED AS THE CATHETER WAS NOT RETURNED FOR ANALYSIS. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Description of Event or Problem · 0

    THE COMPLAINT IS REPORTED AS: WHEN THE CLINICIAN WENT TO THREAD THE PICC CATHETER THROUGH THE SHEATH INTRODUCER, HE WAS UNABLE TO GET THE CATHETER INTO THE SHEATH INTRODUCER. THE FIT WAS TOO TIGHT. AFTER A FEW ATTEMPTS, THE SHEATH INTRODUCER WAS REMOVED AND A DIFFERENT DEVICE WAS USED FOR INTRODUCTION. THE CATHETER PASSED AND WAS PLACED. NO PATIENT INJURY OR COMPLICATION REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE COMPLAINT IS REPORTED AS: WHEN THE CLINICIAN WENT TO THREAD THE PICC CATHETER THROUGH THE SHEATH INTRODUCER, HE WAS UNABLE TO GET THE CATHETER INTO THE SHEATH INTRODUCER. THE FIT WAS TOO TIGHT. AFTER A FEW ATTEMPTS, THE SHEATH INTRODUCER WAS REMOVED AND A DIFFERENT DEVICE WAS USED FOR INTRODUCTION. THE CATHETER PASSED AND WAS PLACED. NO PATIENT INJURY OR COMPLICATION REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1544899 ARROW PI PICC: 2:L 5FR X 55CM W/ 80CM HYDRO NI CATHETER, INTRAVASCULAR, THER LJS ARROW INTERNATIONAL INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1