BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW HEMODIALYSIS KIT: 2-L 15 FR X 27 CM

    MDR report key: 10294949 · Received July 20, 2020

    Report

    Report Number
    9680794-2020-00306
    Event Type
    Malfunction
    Date Received
    July 20, 2020
    Date of Event
    July 8, 2020
    Report Date
    July 8, 2020
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    MSD
    PMA / PMN Number
    K111900
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) THE CUSTOMER PROVIDED ONE PHOTO FOR THIS INVESTIGATION. THE PHOTO WAS OF THE SHEATH THAT HAD SEPARATED INTO TWO PIECES. THE CUSTOMER RETURNED ONE PEEL-AWAY SHEATH FROM A HEMODIALYSIS KIT. NO DEFINITE SIGNS-OF-USE WERE OBSERVED. VISUAL ANALYSIS REVEALED THAT THE SHEATH HAD TORN INCORRECTLY AS THE SHEATH EXTRUSION HAD SEPARATED NEAR THE TABS. THE CATHETER BODY AT THE POINT OF SEPARATION APPEARED RIPPLED AND UNEVEN. A LAB INVENTORY PEEL-AWAY OF THE SAME MATERIAL TYPE WAS PULLED FOR ANALYSIS. THE SEAM ON THE LAB INVENTORY SAMPLE WAS CLEARLY VISIBLE TO THE NAKED EYE AND WAS ALSO EASILY CAPTURED THROUGH MICROSCOPIC EXAMINATION. IN CONTRAST, THE SEAM ON THE COMPLAINT SAMPLE WAS BARELY VISIBLE. THEREFORE, IT WAS CONCLUDED THAT THE PEEL-AWAY BODY DID NOT GET SCORED AS DEEPLY AS INTENDED, WHICH CAUSED THE SEAM TO BE STRONGER THAN NORMAL. THIS LIKELY PREVENTED THE CATHETER FROM PEELING CORRECTLY. THE SHEATH OUTER DIAMETER MEASURED .2452", WHICH IS WITHIN THE SPECIFICATION LIMITS OF .243"-.249" PER THE SHEATH/DILATOR GRAPHIC. THE SHEATH INNER DIAMETER AT THE DISTAL TIP MEASURED .211", WHICH IS WITHIN THE SPECIFICATION LIMITS OF .209"-.212" PER THE SHEATH/DILATOR GRAPHIC. R & D WAS CONTACTED AS PART OF THIS COMPLAINT INVESTIGATION. THEY INDICATED THAT THE PEEL-AWAY EXTRUSION LIKELY DID NOT GET SCORED AS DEEPLY AS INTENDED. THIS WOULD HAVE CAUSED THE SEAM TO BE STRONGER THAN NORMAL. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED WITH NO RELEVANT FINDINGS. THE IFU PROVIDED WITH THE KIT INFORMS THE USER, "SHARPLY SNAP TABS OF VALVE HOUSING IN A PLANE, PERPENDICULAR TO LONG AXIS OF SHEATH TO SPLIT VALVE AND SPLIT SHEATH APART WHILE WITHDRAWING FROM VESSEL". THE REPORT THAT THE SHEATH TEARS INCORRECTLY WAS CONFIRMED THROUGH COMPLAINT INVESTIGATION. VISUAL EXAMINATION REVEALED THAT THE PEEL-AWAY SHEATH EXTRUSION HAD SEPARATED NEAR THE TABS. MICROSCOPIC EXAMINATION REVEALED THAT THE SEAMS WERE NOT CLEARLY DEFINED. CONSULTATION WITH R & D CONFIRMED THAT THE SHEATH BODY LIKELY DID NOT GET SCORED AS DEEPLY AS INTENDED DURING THE MANUFACTURING PROCESS. THIS WOULD HAVE RESULTED IN A STRONGER SEAM AND WOULD HAVE PREVENTED THE CATHETER FROM PEELING CORRECTLY. DESPITE THIS, THE SHEATH MET ALL RELEVANT DIMENSIONAL REQUIREMENTS. BASED ON THE CUSTOMER REPORT AND THE SAMPLE RECEIVED, THE ROOT CAUSE IS LIKELY SUPPLIER RELATED AS THIS IS A PURCHASED COMPONENT. A NON-CONFORMANCE REQUEST WAS INITIATED TO FURTHER INVESTIGATE THIS COMPLAINT ISSUE. 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 SHEATH (TABS) TORE DURING REMOVAL. CLINICAL CONSEQUENCES: THERE WAS NO CONSEQUENCE FOR THE PATIENT, ANOTHER CATHETER WAS USED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT THE PEEL-AWAY SHEATH (TABS) TORE DURING REMOVAL. CLINICAL CONSEQUENCES: THERE WAS NO CONSEQUENCE FOR THE PATIENT, ANOTHER CATHETER WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759311 ARROW HEMODIALYSIS KIT: 2-L 15 FR X 27 CM CATHETER, HEMODIALYSIS, IMPLA MSD ARROW INTERNATIONAL INC. IPN055271 13F20B0333

    Patients

    Seq Age Sex Outcome Treatment
    1