BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM

    MDR report key: 13310671 · Received January 20, 2022

    Report

    Report Number
    3006425876-2022-00013
    Event Type
    Malfunction
    Date Received
    January 20, 2022
    Date of Event
    September 22, 2021
    Report Date
    December 29, 2021
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    MPB
    PMA / PMN Number
    K993933
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4). THE CUSTOMER RETURNED ONE DILATOR FOR ANALYSIS. SIGNS OF USE IN THE FORM OF BIOLOGICAL MATERIAL WAS OBSERVED INSIDE THE DILATOR EXTRUSION AND INSIDE THE DILATOR HUB. VISUAL ANALYSIS OF THE RETURNED DILATOR REVEALED THE TIP WAS SPLIT AND FRAYED. THIS DAMAGE IS CONSISTENT WITH UNDUE FORCE BEING APPLIED TO THE DILATOR DURING AN ATTEMPTED INSERTION. THE DILATOR BODY LENGTH FROM THE HUB TO THE DISTAL TIP MEASURED 5.375" WHICH IS WITHIN THE SPECIFICATION OF 5.250"-5.750" PER THE DILATOR PRODUCT DRAWING. THE DILATOR OUTER DIAMETER MEASURED 4.02MM WHICH IS WITHIN THE SPECIFICATION LIMITS OF 3.97MM-4.06MM PER THE DILATOR EXTRUSION PRODUCT DRAWING. THE DILATOR INNER DIAMETER AT THE DISTAL TIP MEASURED .038" WHICH IS WITHIN THE SPECIFICATION LIMITS OF .036"-.038" PER THE DILATOR PRODUCT DRAWING. A LAB INVENTORY GUIDE WIRE WITH A DIAMETER OF .035" WAS PASSED THROUGH THE DISTAL END OF THE RETURNED DILATOR. THE GUIDE WIRE WAS ABLE TO PASS THOUGH THE DILATOR WITH LITTLE TO NO RESISTANCE. PERFORMED PER THE INSTRUCTIONS FOR USE PROVIDED WITH THE KIT WHICH STATES, "USE DILATOR TO ENLARGE SITE AS REQUIRED". A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND A RELEVANT FINDING WAS IDENTIFIED. FOR LOT 71C20H0946 OF MATERIAL 002200-014040, A NON-CONFORMANCE WAS OPENED FOR SMALLER INNER DIAMETER OF TUBES. THE RETURNED DILATOR MET THE INNER DIAMETER REQUIREMENT; THEREFORE, THE DAMAGE IS UNRELATED TO THIS ISSUE. THE IFU PROVIDED WITH THE KIT INFORMS THE USER "USE DILATOR TO ENLARGE SITE AS REQUIRED. WARNING: DO NOT LEAVE VESSEL DILATOR IN PLACE AS AN INDWELLING CATHETER TO MINIMIZE THE RISK OF POSSIBLE VESSEL WALL PERFORATION". THE CUSTOMER REPORT OF A DAMAGED DILATOR TIP WAS ABLE TO BE CONFIRMED VIA COMPLAINT INVESTIGATION OF THE RETURNED SAMPLE. THE DILATOR TIP WAS SPLIT AND FOLDED AT THE DISTAL TIP. THIS DAMAGE IS CONSISTENT WITH UNDUE FORCE BEING APPLIED TO THE DILATOR DURING AN ATTEMPTED INSERTION. THE RETURNED DILATOR MET ALL RELEVANT FUNCTIONAL/DIMENSIONAL REQUIREMENTS. BASED ON THE RESULTS OF THIS INVESTIGATION AND THE CUSTOMER REPORT THAT THE DAMAGE OCCURRED DURING USE, UNINTENTIONAL USE ERROR LIKELY CAUSED OR CONTRIBUTED TO THIS EVENT. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR COMPLAINTS OF THIS NATURE.

    Additional Manufacturer Narrative · 0

    (B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED WITH ONE RELEVANT FINDING IDENTIFIED. FOR MATERIAL 002200-014040 (DILATOR EXTRUSION) AND LOT 71C20H0946, A NON-CONFORMANCE WAS OPENED RELATED TO SMALLER INNER DIAMETER OF TUBES. MATERIAL WAS RELEASED WITH DISPOSITION UAI. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THE DILATOR TIP WAS FOUND DAMAGED DURING PUNCTURE ON THE PATIENT. NO PATIENT HARM. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Description of Event or Problem · 0

    IT WAS REPORTED THE DILATOR TIP WAS FOUND DAMAGED DURING PUNCTURE ON THE PATIENT. NO PATIENT HARM. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Description of Event or Problem · 0

    IT WAS REPORTED THE DILATOR TIP WAS FOUND DAMAGED DURING PUNCTURE ON THE PATIENT. NO PATIENT HARM. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506979 ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM CATHETER HEMODIALYTSIS NON IMP MPB ARROW INTERNATIONAL INC. 71F21A1494

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown N/A.| N/A.| N/A.