BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW CVC SET: 3-LUMEN 7FR X 20CM

    MDR report key: 16184371 · Received January 17, 2023

    Report

    Report Number
    3006425876-2023-00119
    Event Type
    Malfunction
    Date Received
    January 17, 2023
    Date of Event
    December 23, 2022
    Report Date
    December 23, 2022
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    DQY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE CUSTOMER RETURNED ONE INTRODUCER NEEDLE AND LIDSTOCK FOR ANALYSIS. SIGNS OF USE WERE OBSERVED ON THE NEEDLE CANNULA. VISUAL ANALYSIS REVEALED THAT THE NEEDLE HUB WAS BROKEN AND SEPARATED. A PORTION OF THE DISTAL END OF THE HUB WAS STILL ADHERED TO THE NEEDLE CANNULA. MICROSCOPIC EXAMINATION REVEALED THAT THE POINT OF SEPARATION WAS SMOOTH AT THE CANNULA SEPARATION POINT. AN ADDITIONAL PORTION OF THE HUB BROKE AND SEPARATED, AND WAS NOT RETURNED. IT WAS ALSO CONFIRMED THAT THE HUB ON THE RETURNED SAMPLE IS THE NEW HUB DESIGN, WHICH MATCHES THE BILL OF MATERIALS. FUNCTIONAL INSPECTION WAS NOT ABLE TO BE PERFORMED DUE TO THE DAMAGE TO THE NEEDLE HUB. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND THE FOLLOWING FINDINGS WERE IDENTIFIED: FOR MATERIAL K-04300-019C, A NON-CONFORMANCE WAS INITIATED FOR LOT NUMBERS 14P21D0059, 14P21D0006 AND 14P21D0194 IN REGARDS TO A BROKEN NEEDLE HUB. THE REPORT OF A SEPARATED NEEDLE HUB WAS CONFIRMED BY COMPLAINT INVESTIGATION OF THE RETURNED SAMPLE. VISUAL EXAMINATION REVEALED THE HUB WAS SEPARATED. BASED ON THE SAMPLE PROVIDED, DESIGN CAUSED OR CONTRIBUTED TO THIS EVENT. TELEFLEX HAS IDENTIFIED THAT THE NEEDLE HUB MATERIAL IS SUSCEPTIBLE TO CRACKING WHEN PLACED UNDER STRESS (I.E. PRESSED ONTO A TAPERED LUER FITTING, SIDELOADED AS THE CLINICIAN ATTEMPTS TO LOCATE A VESSEL, ETC.) IN THE PRESENCE OF LIQUID ALCOHOL-BASED DISINFECTANTS. INVESTIGATION OF THIS ISSUE IS DOCUMENTED UNDER A CAPA. 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).

    Description of Event or Problem · 0

    IT WAS REPORTED THE NEEDLE HUB CRACKED DURING PUNCTURE. THE PATIENT IS FINE, NO INJURY OCCURRED. A NEW SET WAS USED SUCCESSFULLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THE NEEDLE HUB CRACKED DURING PUNCTURE. THE PATIENT IS FINE, NO INJURY OCCURRED. A NEW SET WAS USED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1223635 ARROW CVC SET: 3-LUMEN 7FR X 20CM CATHETER, PERCUTANEOUS DQY ARROW INTERNATIONAL LLC IPN919441 71F21H1819

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown OCTENIDERM FROM SCHULKE AND MAYR| OCTENIDERM FROM SCHULKE AND MAYR