MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 7 FR X 20 CM; CATHETER PERCUTANEOUS

Model Number IPN030885

Device Problem Fluid/Blood Leak (1250)

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

Event Date 10/28/2022

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).

Event Description

The complaint is reported as: incident occured on (b)(6) 2022, involved a 32 year-old polytraumatized patient.During surgical rescucitation care, we observed a leak on the median extension line (we do not know where the leak was precisely located on the extension line).The catheter had been inserted on (b)(6) 2022.A new line was inserted in the right jugular.There was no patient injury.The patient's condition is reported as "fine".

Event Description

The complaint is reported as: incident occured on (b)(6) 2022, involved a 32 year-old polytraumatized patient.During surgical resuscitation care, we observed a leak on the median extension line (we do not know where the leak was precisely located on the extension line).The catheter had been inserted on (b)(6) 2022.A new line was inserted in the right jugular.There was no patient injury.The patient's condition is reported as "fine".

Manufacturer Narrative

(b)(4).The customer returned one 3-l catheter for analysis.Signs of use were observed on the catheter body and inside the extension lines.The catheter body appeared intentionally cut.Visual inspection of the returned portion of the catheter revealed no obvious defects or anomalies.The catheter length measured 121mm, which is not within the specifications of 207mm-227mm per product drawing.This indicates that at least 86mm of the catheter was cut and not returned for analysis.The medial extension line outer diameter measured 2.157mm, which is within the specifications of 2.13mm-2.21mm per product drawing.The medial extension line inner diameter measured 1.4478mm, which is within the specifications of 1.42mm-1.50mm per product drawing.This indicates that the wall thickness measured within specifications.Functional inspection of the catheter was performed per the instructions for use (ifu) provided with the kit which states, "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)." the extension lines were flushed using a lab inventory 10ml syringe.The extension lines was tested for liquid leakage per amrq-000071 rev.12 (bs en iso 10555-1 annex c) which states that no liquid leakage should form in one or more falling drops of water when tested at 300kpa for 30 seconds.Each extension line was separately attached to the leak tester, the distal tip of the catheter was occluded, and the leak tester was turned to 300 kpa for 30 seconds.No leaks were found anywhere on the returned portion of the catheter body or extension lines.A manual tug test confirmed the extension lines were fully secured within their respective hubs.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 instructions for use (ifu) provided with this kit warns the user, "do not secure, staple, and/or suture directly to outside diameter of catheter body or extension lines to reduce risk of cutting or damaging the catheter or impeding catheter flow.Secure only at indicated stabilization locations.".The customer report of an extension line leak could not be confirmed through complaint investigation of the returned sample.The catheter met all relevant dimensional and functional requirements, and a device history record review based on a potential lot identified from sales history was performed with no relevant findings.No leaks were observed during leak testing of the returned catheter performed per bs en iso 10555-1.Based on these circumstances, no problem was found with the returned sample.Teleflex will continue to monitor and trend for complaints of this nature.

• Brand Name: ARROW CVC SET: 3-LUMEN 7 FR X 20 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: 16011430
• MDR Text Key: 306928209
• Report Number: 3006425876-2022-01109
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 11/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN030885
• Device Catalogue Number: CV-15703
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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: NOT REPORTED; NOT REPORTED
• Patient Age: 32 YR