BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW CVC SET: 4-LUMEN 8.5FR X 20CM

    MDR report key: 11660259 · Received April 13, 2021

    Report

    Report Number
    3006425876-2021-00312
    Event Type
    Malfunction
    Date Received
    April 13, 2021
    Date of Event
    March 23, 2021
    Report Date
    March 24, 2021
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DQY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    QN# (B)(4). THE CUSTOMER RETURNED ONE INTRODUCER NEEDLE AND A LIDSTOCK FOR ANALYSIS. SIGNS OF USE IN THE FORM OF BIOLOGICAL MATERIAL WAS OBSERVED INSIDE THE NEEDLE HUB. VISUAL ANALYSIS REVEALED THAT THE INTRODUCER NEEDLE HUB WAS SEVERELY CRACKED. THE NEEDLE LENGTH MEASURED 68.5MM WHICH IS WITHIN THE SPECIFICATION LIMITS OF 67.49MM-69.27MM. THE CANNULA OUTER DIAMETER MEASURED .0500" WHICH IS WITHIN THE SPECIFICATION LIMITS OF .0495"-.0505" PER THE CANNULA GRAPHIC. THE CANNULA INNER DIAMETER AT THE DISTAL AND PROXIMAL ENDS MEASURED .041" WHICH IS WITHIN THE SPECIFICATION LIMITS OF .041"-.043" PER THE CANNULA GRAPHIC. THE RETURNED ARS SYRINGE WAS FILLED WITH WATER AND ATTACHED TO THE INTRODUCER NEEDLE. THE PLUNGER WAS FLUSHED, AND WATER WAS OBSERVED LEAKING OUT OF THE CRACKS IN THE HUB. PERFORMED PER IFU STATEMENT "INSERT INTRODUCER NEEDLE WITH ATTACHED ARROW RAULERSON SYRINGE INTO VEIN AND ASPIRATE". THE HUB OF THE NEEDLE WAS TESTED WITH THE MALE LUER GAGE AND WAS NOT WITHIN THE SPECIFIED RANGE DUE TO THE DAMAGE. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. THE REPORTED COMPLAINT OF A CRACKED NEEDLE HUB WAS CONFIRMED BY COMPLAINT INVESTIGATION ON THE RETURNED SAMPLE AND THE CUSTOMER PHOTOS. VISUAL ANALYSIS REVEALED THAT THE RETURNED INTRODUCER NEEDLE HUB WAS CRACKED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. FURTHER INVESTIGATION OF THIS ISSUE IS BEING CONDUCTED UNDER A CAPA. THE CAPA FAILURE INVESTIGATION INDICATES THAT THE PROBABLE CAUSE IS DESIGN RELATED. CORRECTIVE ACTIONS HAVE NOT YET BEEN IMPLEMENTED. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Additional Manufacturer Narrative · 0

    (B)(4). THE ACTUAL DEVICE WAS NOT RETURNED; HOWEVER, THE CUSTOMER PROVIDED TWO PHOTOS FOR EVALUATION. A SINGLE LARGE CRACK WAS OBSERVED IN THE NEEDLE HUB. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND NO RELEVANT FINDINGS WERE IDENTIFIED. THE CUSTOMER REPORT OF A CRACKED NEEDLE HUB WAS CONFIRMED BY COMPLAINT INVESTIGATION OF THE CUSTOMER SUPPLIED PHOTOS. THE NEEDLE HUB CONTAINED ONE LARGE CRACK. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED WITH NO RELEVANT FINDINGS. BASED ON THE PHOTO RECEIVED, DESIGN CAUSED OR CONTRIBUTED TO THIS EVENT. A CAPA HAS BEEN PREVIOUSLY INITIATED TO FURTHER INVESTIGATE THIS ISSUE.

    Description of Event or Problem · 0

    PHYSICIAN INSERTED INTRODUCER NEEDLE INTO RIGHT JUGULAR VEIN. WHEN HE ASPIRATED, HE NOTED "AIR SUCKING INTO THE NEEDLE HUB". IT WAS REPORTED THERE WAS A CRACK IN THE NEEDLE HUB. A NEW NEEDLE WAS OBTAINED AND THE CATHETER WAS INSERTED WITHOUT ANY ISSUES. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Description of Event or Problem · 0

    PHYSICIAN INSERTED INTRODUCER NEEDLE INTO RIGHT JUGULAR VEIN. WHEN HE ASPIRATED, HE NOTED "AIR SUCKING INTO THE NEEDLE HUB". IT WAS REPORTED THERE WAS A CRACK IN THE NEEDLE HUB. A NEW NEEDLE WAS OBTAINED AND THE CATHETER WAS INSERTED WITHOUT ANY ISSUES. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PHYSICIAN INSERTED INTRODUCER NEEDLE INTO RIGHT JUGULAR VEIN. WHEN HE ASPIRATED, HE NOTED "AIR SUCKING INTO THE NEEDLE HUB". IT WAS REPORTED THERE WAS A CRACK IN THE NEEDLE HUB. A NEW NEEDLE WAS OBTAINED AND THE CATHETER WAS INSERTED WITHOUT ANY ISSUES.NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    557426 ARROW CVC SET: 4-LUMEN 8.5FR X 20CM CATHETER, PERCUTANEOUS DQY ARROW INTERNATIONAL INC. 71F20M1081

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male