BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW CVC SET: 16 GA X 8" (20 CM)

    MDR report key: 15494594 · Received September 27, 2022

    Report

    Report Number
    3006425876-2022-00830
    Event Type
    Malfunction
    Date Received
    September 27, 2022
    Date of Event
    August 25, 2022
    Report Date
    September 5, 2022
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    DQY
    PMA / PMN Number
    K862056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4). THE CUSTOMER RETURNED ONE OPENED CVC SET WITH MULTIPLE COMPONENTS INCLUDING AN INTRODUCER NEEDLE FOR ANALYSIS. SIGNS OF USE WERE OBSERVED INSIDE THE NEEDLE HUB. VISUAL ANALYSIS OF THE RETURNED NEEDLE REVEALED ONE SMALL VERTICAL CRACK IN THE NEEDLE HUB. THE NEEDLE LENGTH MEASURED 68MM, WHICH IS WITHIN THE SPECIFICATIONS OF 67.49MM-69.27MM PER NEEDLE PRODUCT DRAWING. THE NEEDLE CANNULA OUTER DIAMETER MEASURED 0.05015" WHICH IS WITHIN THE SPECIFICATIONS OF 0.0495"-0.0505" PER THE CANNULA PRODUCT DRAWING. THE NEEDLE CANNULA INNER DIAMETER MEASURED 0.041" , WHICH IS WITHIN THE SPECIFICATIONS OF 0.041"-0.043" PER THE CANNULA PRODUCT DRAWING. FUNCTIONAL TESTING WAS PERFORMED PER THE PRODUCT IFU, WHICH STATES "INSERT INTRODUCER NEEDLE OR CATHETER/NEEDLE WITH ATTACHED SYRINGE OR ARROW RAULERSON SYRINGE (WHERE PROVIDED) INTO VEIN AND ASPIRATE." THE RETURNED INTRODUCER NEEDLE WAS ATTACHED TO THE RETURNED ARROW RAULERSON SYRINGE (ARS). THE RETURNED NEEDLE WAS NOT ABLE TO DRAW OR ASPIRATE WATER DUE TO THE CRACK IN THE NEEDLE HUB. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND THE FOLLOWING FINDINGS WERE IDENTIFIED: FOR MATERIAL K-04300-019A, BATCH 71P21G0463, THREE NON-CONFORMANCES WERE INITIATED REGARDING AN INSECURE SYRINGE/NEEDLE CONNECTION. THESE FINDINGS ARE NOT RELEVANT TO THIS INVESTIGATION. THE CUSTOMER REPORT OF A CRACKED NEEDLE HUB WAS CONFIRMED THROUGH VISUAL INSPECTION OF THE RETURNED SAMPLE. ONE SMALL VERTICAL CRACK WAS OBSERVED ON THE NEEDLE HUB. THE RETURNED NEEDLE MET ALL RELEVANT DIMENSIONAL REQUIREMENTS, AND A DEVICE HISTORY RECORD REVIEW WAS PERFORMED WITH NO FINDINGS RELEVANT TO THIS INVESTIGATION. IT WAS DETERMINED THAT THE ROOT CAUSE OF THIS COMPLAINT IS LIKELY DESIGN RELATED. A CAPA HAS BEEN INITIATED TO FURTHER INVESTIGATE THIS ISSUE. CORRECTIVE ACTIONS HAVE NOT YET BEEN IMPLEMENTED. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR COMPLAINTS OF THIS NATURE.

    Description of Event or Problem · 0

    IT WAS REPORTED ON (B)(6) 2022, THE DOCTOR FOUND THE SYRINGE/NEEDLE CONNECTION NOT SECURE DURING USE ON THE PATIENT. THERE WAS NO MEDICAL INTERVENTION AND THE PATIENT'S CONDITION WAS REPORTED AS FINE.

    Description of Event or Problem · 0

    IT WAS REPORTED ON (B)(6) 2022, THE DOCTOR FOUND THE SYRINGE/NEEDLE CONNECTION NOT SECURE DURING USE ON THE PATIENT. THERE WAS NO MEDICAL INTERVENTION AND THE PATIENT'S CONDITION WAS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1905437 ARROW CVC SET: 16 GA X 8" (20 CM) CATHETER PERCUTANEOUS DQY ARROW INTERNATIONAL LLC 71F21H1429

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Unknown N/A.| N/A.