BEUDAMED
    FDA Adverse Event Death Summary report: N

    ARROW CVC KIT: 16 GA X 20 CM

    MDR report key: 14938550 · Received July 6, 2022

    Report

    Report Number
    3006425876-2022-00572
    Event Type
    Death
    Date Received
    July 6, 2022
    Date of Event
    June 10, 2022
    Report Date
    June 13, 2022
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    DQY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 0

    QN#(B)(4). THE CUSTOMER PROVIDED ONE PICTURE OF THE COMPLAINT SAMPLE. THE IMAGE SHOWS A SINGLE-LUMEN CATHETER WITH LUER HUB SEPARATED FROM THE EXTENSION LINE. EVIDENCE OF USE CAN BE OBSERVED, AND THE SEPARATED LUER HUB IS ATTACHED TO THE TUBING SET. THE CUSTOMER ALSO RETURNED ONE SINGLE LUMEN CVC FOR EVALUATION. A NON-ARROW TUBING SET WAS ALSO RETURNED UNATTACHED TO THE CATHETER. SIGNS OF USE WERE OBSERVED ON THE CATHETER BODY AND INSIDE THE EXTENSION LINES. VISUAL INSPECTION OF THE CATHETER REVEALED THE DISTAL LUER HUB WAS SEPARATED FROM THE DISTAL EXTENSION LINE. PIECES OF THE EXTENSION LINE MOLDING WERE STILL VISIBLE INSIDE THE LUER HUB. THE EXTENSION LINE SEPARATION POINT WAS OBSERVED TO BE ROUGH AND JAGGED. NO DAMAGE OR ANOMALIES WERE OBSERVED ON THE TUBING SET. THE DISTAL EXTENSION LINE OUTER DIAMETER MEASURED 2.136MM WHICH IS WITHIN THE SPECIFICATIONS OF 2.13-2.21MM PER DISTAL EXTENSION LINE EXTRUSION PRODUCT DRAWING. THE DISTAL EXTENSION LINE INNER DIAMETER MEASURED 1.42MM, WHICH IS WITHIN THE SPECIFICATIONS OF 1.41-1.50MM PER DISTAL EXTENSION LINE EXTRUSION PRODUCT DRAWING. THIS INDICATES THAT THE WALL THICKNESS MEASURED WITHIN SPECIFICATIONS. THE COMBINED EXTENSION LINE LENGTH (INCLUDING SEPARATED LUER HUB) MEASURED 114 MM WHICH IS NOT WITHIN THE SPECIFICATION OF 98.5-113.5 MM PER CATHETER PRODUCT DRAWING. THIS INDICATES THAT THE EXTENSION LINE MATERIAL SLIGHTLY STRETCHED PRIOR TO THE SEPARATION. IN ORDER TO CHECK FOR CATHETER BLOCKAGES A LAB INVENTORY GUIDE WIRE WAS ADVANCED THROUGH THE CATHETER VIA THE DISTAL TIP PER THE PRODUCT'S INSTRUCTIONS-FOR-USE: "THREAD TIP OF CATHETER OVER SWG. SUFFICIENT SWG LENGTH MUST REMAIN EXPOSED AT HUB END OF CATHETER TO MAINTAIN A FIRM GRIP ON SWG."THE GUIDE WIRE ADVANCED THROUGH THE CATHETER AS EXPECTED WITH NO RESISTANCE OR BLOCKAGES OBSERVED. THE CUSTOMER DID NOT PROVIDE A LOT NUMBER; THEREFORE, A DEVICE HISTORY RECORD REVIEW WAS PERFORMED BASED UPON A LOT NUMBER FROM THE SALES HISTORY DATA OF THE CUSTOMER. NO RELEVANT FINDINGS WERE IDENTIFIED. THE REPORT OF AN EXTENSION LINE/LUER HUB SEPARATION WAS CONFIRMED THROUGH INVESTIGATION OF THE RETURNED SAMPLE. VISUAL ANALYSIS REVEALED THAT THE DISTAL EXTENSION LINE HAD SEPARATED ADJACENT TO THE LUER HUB. IT WAS NOTED THAT REMAINS OF THE EXTENSION LINE WERE FOUND WITHIN THE DISTAL LUER HUB. A CAPA HAS PREVIOUSLY BEEN INITIATED DUE TO AN INCREASING TREND OF CVC EXTENSION LINE LEAKS AND SEPARATIONS. THE CAPA INVESTIGATION INDICATED THE ROOT CAUSE OF THIS ISSUE IS MANUFACTURING RELATED. CORRECTIVE ACTIONS HAVE NOT YET BEEN IMPLEMENTED, BUT ARE UNDER INVESTIGATION AND EVALUATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND COMPLAINTS OF THIS NATURE.

    Description of Event or Problem · 0

    CATHETER WAS INSERTED ON (B)(6) 2022 FOR HIGH-CALORIE INFUSION OF SOLDEM 3A. ON (B)(6) 2002, AT 1:30PM, THE NURSE CHECKED THE PATIENT AND CATHETER AND FOUND NO PROBLEMS AT THAT TIME. BETWEEN 1:30PM AND 3:30PM THE PATIENT WENT TO THE BATHROOM CLOSE BY HIS BED. IT WAS REPORTED AT 3:30PM THE SAME DAY, THE EXTENSION LINE WAS FOUND SEPARATED FROM THE LUER HUB OF THE CATHETER, AND THE PATIENT WAS CONFIRMED DEAD. THE PHYSICIAN REPORTED THE EXTENSION LINE SEEMED TO "BREAK OFF" FROM THE LUER HUB AND MAY HAVE GOTTEN CAUGHT ON SOMETHING WHEN THE PATIENT WENT TO THE BATHROOM. PER THE PHYSICIAN, AN AIR EMBOLISM MAY HAVE RESULTED IN THE PATIENT'S DEATH; HOWEVER, THE DEFINITE CAUSE OF THE PATIENT'S DEATH IS UNKNOWN BECAUSE THE PATIENT'S FAMILY DID NOT WANT AN AUTOPSY. THE PATIENT'S DEATH CERTIFICATE LISTS "HEPATIC METASTASIS AFTER THE SURGERY FOR CANCER OF THE STOMACH" AS THE CAUSE OF DEATH.

    Description of Event or Problem · 0

    CATHETER WAS INSERTED ON (B)(6) 2022 FOR HIGH-CALORIE INFUSION OF SOLDEM 3A. ON (B)(6) 2002, AT 1:30PM, THE NURSE CHECKED THE PATIENT AND CATHETER AND FOUND NO PROBLEMS AT THAT TIME. BETWEEN 1:30PM AND 3:30PM THE PATIENT WENT TO THE BATHROOM CLOSE BY HIS BED. IT WAS REPORTED AT 3:30PM THE SAME DAY, THE EXTENSION LINE WAS FOUND SEPARATED FROM THE LUER HUB OF THE CATHETER, AND THE PATIENT WAS CONFIRMED DEAD. THE PHYSICIAN REPORTED THE EXTENSION LINE SEEMED TO "BREAK OFF" FROM THE LUER HUB AND MAY HAVE GOTTEN CAUGHT ON SOMETHING WHEN THE PATIENT WENT TO THE BATHROOM. PER THE PHYSICIAN, AN AIR EMBOLISM MAY HAVE RESULTED IN THE PATIENT'S DEATH; HOWEVER, THE DEFINITE CAUSE OF THE PATIENT'S DEATH IS UNKNOWN BECAUSE THE PATIENT'S FAMILY DID NOT WANT AN AUTOPSY. THE PATIENT'S DEATH CERTIFICATE LISTS "HEPATIC METASTASIS AFTER THE SURGERY FOR CANCER OF THE STOMACH" AS THE CAUSE OF DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1423921 ARROW CVC KIT: 16 GA X 20 CM CATHETER, PERCUTANEOUS DQY ARROW INTERNATIONAL LLC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Male Death SOLDEM 3A, NARCOTIC ANALGESICS| SOLDEM 3A, NARCOTIC ANALGESICS