MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 2-LUMEN 7 FR X 16 CM; CATHETER PERCUTANEOUS

Model Number	IPN918695
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Associated mdr#s: 3006425876-2023-00517.
Event or Problem Description
It was reported that "after inserting the cvc under ultrasound guide lot 71f22j0989, we confirmed that when flushing the distal line there is 2 exits points (the distal and proximal one) and after the insertion on the jugular vein that when we aspirating on the proximal line, we observed a constant bubbling (bubbles with each aspiration).It was decided to change the device for same reference lot 71f22h1928 but the same issue was observed.It was then decided to abandon the 2 way cvc and to insert a single cvc without any difficulty.Post insertion x-ray confirmed successful insertion." there was no patient harm or injury.The patient's condition is reported as "very good health".
Additional Manufacturer Narrative
(b)(4).Associated mdr#s: 3006425876-2023-00439 and 3006425876-2023-00517.The customer returned one 2-l catheter for evaluation.Visual inspection of the catheter revealed no obvious defects or anomalies.Per the catheter graphic, there are two exit points for the distal extension line, both of which are present on the catheter body.The catheter body total length measured 167mm, which is within the specifications of 157-177mm per product drawing.The second distal lumen exit hole was located 25mm from the distal tip, which is within the specifications of 21-29mm per product drawing.Functional inspection was performed per the product ifu which states, "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)." the catheter lumens were flushed using a lab inventory 10cc syringe.Both lumens flushed normally.Water exited both distal lumen exit points when the distal lumen was flushed, and water exited the proximal skive hole when the proximal lumen was flushed.No inter-lumen crossover was observed during functional testing.No leaks or blockages were observed anywhere on the catheter body.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with the kit warns the user, "using catheters not indicated for pressure injection for such applications can result in inter-lumen crossover or rupture with potential for injury." the customer report of inter-lumen crossover during use could not be confirmed through complaint investigation of the returned sample.The catheter contained both required distal lumen exit holes.Flushing of the proximal lumen resulted in fluid exiting only the proximal skive.The returned catheter met all relevant dimensional and functional requirements, and a device history record review was performed with no relevant findings.Based on these circumstances, no problem was found with the returned sample.Teleflex will continue to monitor and trend for complaints of this nature.
Event or Problem Description
It was reported that "after inserting the cvc under ultrasound guide lot 71f22j0989, we confirmed that when flushing the distal line there is 2 exits points (the distal and proximal one) and after the insertion on the jugular vein that when we aspirating on the proximal line, we observed a constant bubbling (bubbles with each aspiration).It was decided to change the device for same reference lot 71f22h1928 but the same issue was observed.It was then decided to abandon the 2 way cvc and to insert a single cvc without any difficulty.Post insertion x-ray confirmed successful insertion." there was no patient harm or injury.The patient's condition is reported as "very good health.".

• Brand Name: ARROW CVC SET: 2-LUMEN 7 FR X 16 CM
• Common Device Name: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 16885495
• Report Number: 3006425876-2023-00439
• Device Sequence Number: 20374233
• Product Code: DQY
• UDI-Device Identifier: 10801902182675
• UDI-Public: 10801902182675
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2026
• Device Model Number: IPN918695
• Device Catalogue Number: CV-12712
• Device Lot Number: 71F22J0989
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2023
• Supplement Date Received by Manufacturer: 06/02/2023
• Initial Report FDA Received Date: 05/08/2023
• Supplement Report FDA Received Date: 06/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown