BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW CVC SET: 2-LUMEN 7 FR X 16 CM

    MDR report key: 8539904 · Received April 23, 2019

    Report

    Report Number
    3006425876-2019-00306
    Event Type
    Malfunction
    Date Received
    April 23, 2019
    Date of Event
    April 1, 2019
    Report Date
    April 10, 2019
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DQY
    PMA / PMN Number
    K862056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER RETURNED A 2-LUMEN CVC CATHETER FOR INVESTIGATION. VISUAL INSPECTION OF THE CATHETER REVEALED THE PROXIMAL LUER HUB WAS SEPARATED FROM THE EXTENSION LINE. THE LUER HUB WAS NOT RETURNED. DIMENSIONAL INSPECTION CONFIRMED THAT THE EXTENSION LINE MOST LIKELY SEPARATED ADJACENT TO THE LUER HUB. VISUAL INSPECTION OF THE POINT OF SEPARATION REVEALED THAT SURFACE WAS ROUGH AND JAGGED. THE LENGTH OF THE PROXIMAL EXTENSION LINE (FROM THE TORN PROXIMAL END TO THE PROXIMAL END OF THE JUNCTURE HUB) MEASURED 109 MM, WHICH IS WITHIN THE SPECIFICATION OF 108.90 MM - 109.90 MM PER CATHETER DRAWING. THEREFORE, NO PIECES OF THE EXTENSION LINE APPEAR TO BE MISSING AND CONFIRMS THAT THE EXTENSION LINE MOST LIKELY SEPARATED ADJACENT TO THE LUER HUB. THE PROXIMAL EXTENSION LINE INNER AND OUTER DIAMETER WERE MEASURED AND WERE FOUND TO BE WITHIN SPECIFICATION. THIS INDICATES THERE IS NO ISSUE WITH THE EXTENSION LINE WALL THICKNESS. THE LOT NUMBER WAS NOT REPORTED; THEREFORE A DEVICE HISTORY RECORD REVIEW WAS PERFORMED BASED ON A POTENTIAL LOT NUMBER FROM THE SALES HISTORY OF THE CUSTOMER. NO RELEVANT FINDINGS WERE IDENTIFIED. THE IFU PROVIDED WITH THE KIT WARNS THE USER "DO NOT APPLY EXCESSIVE FORCE IN REMOVING GUIDE WIRE OR CATHETER. IF WITHDRAWAL CANNOT BE EASILY ACCOMPLISHED, A CHEST X-RAY SHOULD BE OBTAINED, AND FURTHER CONSULTATION REQUESTED." THE IFU ALSO WARNS TO OPEN THE CATHETER CLAMP PRIOR TO INFUSION THROUGH LUMEN TO REDUCE THE RISK OF DAMAGE TO EXTENSION LINE(S) FROM EXCESSIVE PRESSURE. IN ADDITION, THE IFU STATES "DO NOT SECURE, STAPLE, AND/OR SUTURE DIRECTLY TO OUTSIDE DIAMETER OF CATHETER BODY OR EXTENSION LINES TO REDUCE THE RISK OF CUTTING OR DAMAGING THE CATHETER OR IMPEDING CATHETER FLOW. SECURE ONLY AT INDICATED STABILIZATION LOCATIONS." THE CUSTOMER REPORT OF EXTENSION LINE/LUER HUB SEPARATION WAS CONFIRMED BY COMPLAINT INVESTIGATION. VISUAL AND MICROSCOPIC EXAMINATION OF THE RETURNED CATHETER REVEALED THE PROXIMAL EXTENSION LINE LUER HUB WAS SEPARATED FROM THE CATHETER, AND THE POINT OF SEPARATION ON THE EXTENSION LINE WAS ROUGH AND JAGGED. THE EXTENSION LINE PASSED ALL RELEVANT DIMENSIONAL INSPECTION; HOWEVER, THE LUER HUB WAS NOT RETURNED FOR INVESTIGATION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED WITH NO RELEVANT FINDINGS TO SUGGEST A MANUFACTURING RELATED ISSUE. SINCE THE LUER HUB WAS NOT RETURNED FOR EVALUATION, THE PROBABLE ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE SAMPLE RECEIVED AND THE INFORMATION PROVIDED. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR COMPLAINTS OF THIS NATURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT: IN THE SCEPTIC SURGERY DEPARTMENT, IT WAS OBSERVED A SEPARATION OF THE EXTENSION LINE. THE LINE WAS SEPARATED AND FOUND IN THE BED OF THE PATIENT, STAFF NOTICED BUBBLES IN THE FIRST PART OF THE LINE. CLINICAL CONSEQUENCES: A PERIPHERAL LINE WAS INSERTED IN ORDER THE PATIENT TO GET HER TREATMENT. THERE WAS NO HEMORRHAGE.

    Additional Manufacturer Narrative · 1

    (B)(4). POTENTIAL LOT# 71F19A2846.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: IN THE SCEPTIC SURGERY DEPARTMENT, IT WAS OBSERVED A SEPARATION OF THE EXTENSION LINE. THE LINE WAS SEPARATED AND FOUND IN THE BED OF THE PATIENT, STAFF NOTICED BUBBLES IN THE FIRST PART OF THE LINE. CLINICAL CONSEQUENCES: A PERIPHERAL LINE WAS INSERTED IN ORDER THE PATIENT TO GET HER TREATMENT. THERE WAS NO HEMORRHAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332487 ARROW CVC SET: 2-LUMEN 7 FR X 16 CM CATHETER PERCUTANEOUS DQY ARROW INTERNATIONAL INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1