BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW DRAINAGE SET

    MDR report key: 11043332 · Received December 20, 2020

    Report

    Report Number
    9680794-2020-00523
    Event Type
    Malfunction
    Date Received
    December 20, 2020
    Date of Event
    November 30, 2020
    Report Date
    November 30, 2020
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    GBX
    PMA / PMN Number
    K895516
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE CUSTOMER RETURNED A DRAINAGE CATHETER FOR ANALYSIS. SIGNS-OF-USE IN THE FORM OF WHAT APPEARS TO BE DRIED BIOLOGICAL MATERIAL WAS OBSERVED ON THE DISTAL SKIVE HOLE ON THE CATHETER BODY. VISUAL ANALYSIS REVEALED THAT THE CATHETER BODY CONTAINED A HOLE DIRECTLY ADJACENT TO THE JUNCTURE HUB. THE EDGES OF THE HOLE APPEAR JAGGED YET UNIFORM, WHICH IS CONSISTENT WITH UNDUE FORCE BEING APPLIED TO THE EXTRUSION. THE CATHETER BODY LENGTH MEASURED 9 3/4", WHICH IS WITHIN THE SPECIFICATION LIMITS OF 9 9/16"-9 15/16" PER THE CATHETER GRAPHIC. THE CATHETER BODY OUTER DIAMETER MEASURED .1835", WHICH IS WITHIN THE SPECIFICATION LIMITS OF .182"-.186" PER THE CATHETER EXTRUSION GRAPHIC. THE CATHETER BODY INNER DIAMETER MEASURED .134," WHICH IS WITHIN THE SPECIFICATION LIMITS OF .132"-.136" PER THE CATHETER EXTRUSION GRAPHIC. AFTER THE DISTAL TIP WAS OCCLUDED AND THE DRAINAGE TUBE WAS BLOCKED WITH A GLOVED THUMB, A 10ML SYRINGE WAS CONNECTED TO THE EXTENSION LINE AND THE CATHETER WAS PRESSURIZED. WATER COULD BE SEEN LEAKING OUT OF THE SMALL HOLE IN THE CATHETER BODY. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. THE IFU PROVIDED WITH THIS KIT WARNS THE USER "TO ENSURE ALL DRAINAGE HOLES ARE WITHIN CAVITY, A MINIMUM OF 12 CM MUST BE ADVANCED." THE IFU ALSO STATES, "DO NOT SUTURE DIRECTLY TO OUTSIDE DIAMETER OF CATHETER TO MINIMIZE THE RISK OF CUTTING OR DAMAGING CATHETER OR IMPEDING CATHETER PERFORMANCE." THE CUSTOMER REPORT OF A LEAK WAS CONFIRMED BY COMPLAINT INVESTIGATION. THE CATHETER BODY CONTAINED ONE SMALL HOLE DIRECTLY ADJACENT TO THE JUNCTURE HUB. THE SLIT WAS CONSISTENT WITH THE CATHETER BEING TORN DUE TO UNDUE FORCE BEING APPLIED DURING THE PROCEDURE. THE CATHETER MET ALL RELEVANT DIMENSIONAL REQUIREMENTS, AND A DEVICE HISTORY RECORD REVIEW WAS COMPLETED WITH NO RELEVANT FINDINGS. BASED ON THE APPEARANCE OF THE DAMAGE AND THE CUSTOMER REPORT THAT THE DEFECT WAS IDENTIFIED DURING USE, UNINTENTIONAL USER ERROR LIKELY CAUSED OR CONTRIBUTED TO THIS EVENT. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR COMPLAINTS OF THIS NATURE.

    Description of Event or Problem · 0

    THE COMPLAINT IS REPORTED AS: "THE INTRODUCER CATHETER IS BROKEN." IT WAS REPORTED DURING INSERTION THE "TEAR-OFF DISTAL AT THE FIXATION RING" WAS BROKEN. THE DEVICE WAS REPLACED. NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "INTENSIVE CARE MEDICINE MONITORING REQUIRED."

    Additional Manufacturer Narrative · 1

    QN#: (B)(4).

    Description of Event or Problem · 1

    THE COMPLAINT IS REPORTED AS: "THE INTRODUCER CATHETER IS BROKEN". IT WAS REPORTED DURING INSERTION THE "TEAR-OFF DISTAL AT THE FIXATION RING" WAS BROKEN. THE DEVICE WAS REPLACED. NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "INTENSIVE CARE MEDICINE MONITORING REQUIRED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1508209 ARROW DRAINAGE SET CATHETER IRRIGATION GBX ARROW INTERNATIONAL INC. 13F20F0529

    Patients

    Seq Age Sex Outcome Treatment
    1 NONE REPORTED.| NONE REPORTED.