MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 7 FR X 30 CM; CATHETER PERCUTANEOUS

Catalog Number CS-14703

Device Problem Obstruction of Flow (2423)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/14/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported "lumen blockage." new set was used to complete the procedure.Patient condition was reported as "fine and was discharged.".

Manufacturer Narrative

(b)(4).The customer returned one 3-l cvc catheter for analysis.Definite signs of use were observed in the extension lines and catheter body.Visual analysis of the catheter revealed blood within the catheter extrusion and extension lines.After failing functional testing, congealed blood was observed within the proximal lumen of the catheter extrusion.The overall length of the catheter measured 315mm which is within the specification limits of 307mm - 327 mm per the catheter product drawing.The outer diameter of the catheter measured 2.442mm which is within the specification limits of 2.39mm - 2.49mm per the catheter extrusion graphic.The catheter was functionally tested per the instructions for use (ifu) provided with this kit , which states "check lumen patency by attaching a syringe to each extension line and aspirate until free flow of venous blood is observed." the extension lines were flushed with a lab inventory syringe, and the medial and distal extension lines flushed as intended.A blockage was encountered when flushing the proximal extension line.A lab inventory long pin gauge was inserted through the extension line to remove the blockage, but it could not be removed.The catheter body was then cross sectioned at the approximate location of the blockage, and congealed biological material was observed in the proximal lumen.A manual tug test confirmed that the luer hubs were secure within their respective hubs.A device history record review was performed, and no relevant findings were identified.The ifu provided with this kit informs the user," check lumen patency by attaching a syringe to each extension line and aspirate until free flow of venous blood is observed.Flush lumen(s) to completely clear blood from catheter." the customer report of a blocked catheter was confirmed through the complaint investigation.Visual and functional analysis revealed that the proximal extension line was blocked by congealed biological material within the catheter body.The catheter passed all relevant dimensional requirements, and a device history record review revealed no relevant findings.Based on the customer report and the sample received , unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.

Event Description

It was reported "lumen blockage." new set was used to complete the procedure.Patient condition was reported as "fine and was discharged.".

• Brand Name: ARROW CVC SET: 3-LUMEN 7 FR X 30 CM
• Type of Device: 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: 16121202
• MDR Text Key: 306899398
• Report Number: 3006425876-2023-00062
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K862056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/14/2022

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
• Device Catalogue Number: CS-14703
• Device Lot Number: 71F20C0598
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/14/2022
• Initial Date FDA Received: 01/09/2023
• Supplement Dates Manufacturer Received: 01/27/2023
• Supplement Dates FDA Received: 02/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NONE REPORTED; NONE REPORTED