BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW CVC KIT: 3-LUMEN 8,5FR X 20CM

    MDR report key: 12328142 · Received August 16, 2021

    Report

    Report Number
    3006425876-2021-00751
    Event Type
    Malfunction
    Date Received
    August 16, 2021
    Date of Event
    July 27, 2021
    Report Date
    July 29, 2021
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DQY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    QN#(B)(4). THE CUSTOMER PROVIDED ONE IMAGE SHOWING A DEFECTIVE INTRODUCER NEEDLE. VISUAL ANALYSIS REVEALED THAT THE NEEDLE HUB HAD CRACKED AND SEPARATED. A PORTION OF THE NEEDLE HUB WAS STILL MOLDED TO THE CANNULA. THE CUSTOMER RETURNED ONE INTRODUCER NEEDLE FOR ANALYSIS. SIGNS-OF-USE IN THE FORM OF BIOLOGICAL MATERIAL WAS OBSERVED. THE SEPARATED PORTION OF THE HUB WAS NOT RETURNED FOR ANALYSIS. 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 SLIGHTLY ROUGH BUT UNIFORM. IT WAS ALSO OBSERVED THAT THE NEEDLE CANNULA WAS BENT; HOWEVER, AS THIS WAS NOT PRESENT ON THE CUSTOMER SUPPLIED IMAGE, IT IS BEING ASSUMED THAT THIS OCCURRED WHILE IN TRANSIT TO THE MORRISVILLE FACILITY. 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 A SEPARATED NEEDLE HUB WAS CONFIRMED BY COMPLAINT INVESTIGATION OF THE RETURNED SAMPLE. VISUAL EXAMINATION REVEALED THE HUB WAS PARTIALLY SEPARATED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED BASED ON SALES HISTORY, AND NO RELEVANT FINDINGS WERE IDENTIFIED. BASED ON THE SAMPLE PROVIDED AND THE CUSTOMER IMAGE, DESIGN CAUSED OR CONTRIBUTED TO THIS EVENT. FURTHER INVESTIGATION OF THIS ISSUE IS BEING PERFORMED UNDER A CAPA. CORRECTIVE ACTION HAS NOT YET BEEN IMPLEMENTED. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "DURING A SUBCLAVIAN PUNCTURE, THE HUB OF THE PUNCTURE NEEDLE BROKE". NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE. ANOTHER DEVICE WAS OBTAINED FOR USE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "DURING A SUBCLAVIAN PUNCTURE, THE HUB OF THE PUNCTURE NEEDLE BROKE". NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE. ANOTHER DEVICE WAS OBTAINED FOR USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1224098 ARROW CVC KIT: 3-LUMEN 8,5FR X 20CM CATHETER, PERCUTANEOUS DQY ARROW INTERNATIONAL INC. IPN038281 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1