MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3L 7 FR X 16 CM; CATHETER PERCUTANEOUS

Model Number IPN030078

Device Problem Fluid/Blood Leak (1250)

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

Event Date 11/09/2022

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).Associated mdr#s: 3006425876-2022-01108; and 3006425876-2022-01107.

Event Description

It was reported the nurse went to sample blood from the catheter that had been inserted on 28 october and found the proximal line was leaking.The medial line had no reflux (blockage/occlusion), and the distal line was wrapped in a band and had an anti-reflux connector on it.The band was removed and the line was checked.There was no reflux but presence of air and leaks and the line had a hole in it.The distal line was immediately clamped and the cather was removed.A chest x-ray was performed.It was reported there was no patient injury and no medical intervention was required.The patient's condition is reported as "fine".

Manufacturer Narrative

(b)(4).Associated mdr#s: 3006425876-2022-01108; 3006425876-2022-01107.The customer returned one 3-l cvc for analysis.Signs of use were observed on the catheter body and inside the extension lines.The catheter appeared intentionally cut.The separated portion was not returned.Initial visual inspection of the catheter and proximal extension line did not reveal any obvious defects or anomalies.The proximal extension line was observed to have a significant accumulation of biomaterial, causing a blockage, however, no holes/leaks were observed.The catheter body length measured 88mm, which is not within the specifications of 157mm-177mm per product drawing.This indicates that 69mm-89mm of the catheter were cut and not returned for analysis.The proximal extension line outer diameter measured 2.196mm, which is within the specifications of 2.13mm-2.21mm per product drawing.The proximal extension line inner diameter measured 1.4732 mm, 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 proximal extension line was attached to the lab inventory syringe and flushed.Initially, no water was observed exiting the catheter despite significant pressure applied, indicating the presence of a blockage.A long pin gauge was inserted into the proximal extension line to determine the source of the blockage.The blockage was observed to be approximately 1" from the distal end of the catheter.The catheter was cut at the location of the blockage for further inspection.It was determined that large amounts of dried biomaterial were lodged inside the proximal line.The blockage was dislodged, and the extension line was attempted to be flushed again.This time, water was observed exiting the distal end of the catheter.No leaks or additional blockages were observed.The proximal extension line 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.The proximal extension line was 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 catheter body or proximal extension line.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.Functional inspection of the proximal extension line revealed a blockage, which was then further inspected and revealed to be caused by an accumulation of dried biomaterial inside the extension line, however, once cleared the extension line flushed as expected.No leaks were observed during functional testing performed according to bs en iso 10555-1 annex c.Based on the customer report and the sample returned, no problem was found relating to leakage for the proximal extension line.Teleflex will continue to monitor and trend for complaints of this nature.

Event Description

It was reported the nurse went to sample blood from the catheter that had been inserted on 28 october and found the proximal line was leaking.The medial line had no reflux (blockage/occlusion), and the distal line was wrapped in a band and had an anti-reflux connector on it.The band was removed and the line was checked.There was no reflux but presence of air and leaks and the line had a hole in it.The distal line was immediately clamped and the cather was removed.A chest x-ray was performed.It was reported there was no patient injury and no medical intervention was required.The patient's condition is reported as "fine".

• Brand Name: ARROW CVC SET: 3L 7 FR X 16 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: 15991670
• MDR Text Key: 306927691
• Report Number: 3006425876-2022-01098
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801902102133
• UDI-Public: 00801902102133
• 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: 11/25/2022

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 Operator: Health Professional
• Device Model Number: IPN030078
• Device Catalogue Number: CS-12703-E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/25/2022
• Initial Date FDA Received: 12/15/2022
• Supplement Dates Manufacturer Received: 01/17/2023
• Supplement Dates FDA Received: 01/18/2023
• 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