BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 6656548 · Received June 21, 2017

    Report

    Report Number
    3006425876-2017-00198
    Event Type
    Malfunction
    Date Received
    June 21, 2017
    Date of Event
    June 2, 2017
    Report Date
    June 2, 2017
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DQY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE CATHETER AND NO RELEVANT FINDINGS WERE IDENTIFIED. WITHOUT THE DEVICE TO EVALUATE, THE COMPLAINT COULD NOT BE CONFIRMED AND THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER RETURNED A USED MCZ-15703-004 CATHETER, A K-14703-013A CATHETER CLAMP, AND A K-14703-007A CATHETER CLAMP FASTENER. THE SUTURE SITES FOR EACH ITEM WERE VISUALLY INSPECTED. ONE OF THE SUTURE POINTS ON THE CATHETER CLAMP WAS OBLONG, INDICATING USE. THERE WERE NO SIGNS OF USE ON THE JUNCTURE HUB SUTURE WINGS. THE CATHETER BODY OUTER DIAMETER WAS MEASURED AND FOUND TO BE WITHIN SPECIFICATION. THE CATHETER CLAMP FASTENER DIAMETER AND THE CATHETER CLAMP INNER DIAMETER WERE ALSO MEASURED AND FOUND TO BE WITHIN SPECIFICATION. THE CLAMP AND THE CLAMP FASTENER WERE REASSEMBLED. THE LARGEST PIN GAUGE THAT WOULD PASS THROUGH THE CLAMP ASSEMBLY WITHOUT RESISTANCE WAS 0.050". THIS INDICATES THAT THE CLAMP WOULD SECURELY HOLD A CATHETER THAT HAS AN OUTER DIAMETER OF 0.096". THE BOX CLAMP WAS PLACED ON THE CATHETER AND THE CATHETER BODY WAS THEN TUGGED ON EITHER SIDE. THE CATHETER REMAINED IN PLACE. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED AND NO RELEVANT FINDINGS WERE FOUND. OTHER REMARKS: THE CUSTOMER STATES THAT THE CATHETER MIGRATED "EVEN THOUGH THE CATHETER WAS SECURED TO THE PATIENT BY SUTURING THE WHITE AND BLUE BOX CLAMP AND FASTENER TOGETHER TO THE SKIN, THE USER FOUND THE CATHETER MIGRATION". DURING THE VISUAL INSPECTION IT WAS FOUND THAT THE SUTURE WINGS ON THE CATHETER HUB DID NOT HAVE ANY SIGNS OF USE, CONFIRMING THAT ONLY THE CLAMP AND FASTENER WERE USED TO SECURE THE CATHETER. THE PRODUCT IFU WAS REVIEWED AND IT STATES THAT THE CATHETER HUB IS THE PRIMARY SECUREMENT SITE WHILE THE CATHETER CLAMP AND FASTENER ARE TO BE USED AS A SECONDARY SITE. THE PROBABLE CAUSE OF THIS ISSUE WAS DETERMINED TO BE OPERATIONAL CONTEXT, THEREFORE NO ADDITIONAL ACTION SHALL BE TAKEN.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE PRODUCT IS NOT INTENDED FOR SALE IN THE US. A SIMILAR PRODUCT IS SOLD IN THE US.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT ALTHOUGH THE CATHETER WAS SECURED TO THE PATIENT BY SUTURING THE WHITE AND BLUE BOX CLAMP AND FASTENER TO THE SKIN, THE USER FOUND THE CATHETER MIGRATED. NO PATIENT INJURY OR COMPLICATION REPORTED

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT ALTHOUGH THE CATHETER WAS SECURED TO THE PATIENT BY SUTURING THE WHITE AND BLUE BOX CLAMP AND FASTENER TO THE SKIN, THE USER FOUND THE CATHETER MIGRATED. NO PATIENT INJURY OR COMPLICATION REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT ALTHOUGH THE CATHETER WAS SECURED TO THE PATIENT BY SUTURING THE WHITE AND BLUE BOX CLAMP AND FASTENER TO THE SKIN, THE USER FOUND THE CATHETER MIGRATED. NO PATIENT INJURY OR COMPLICATION REPORTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437250 ARROW CVC KIT: 3-LUMEN 7 FR X 20 CM CATHETER, PERCUTANEOUS DQY ARROW INTERNATIONAL INC. 71F16L0067

    Patients

    Seq Age Sex Outcome Treatment
    1