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

Catalog Number JP-14703-C

Device Problem Material Separation (1562)

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

Event Date 04/20/2022

Event Type  malfunction  

Event Description

It was reported that, after placement of the catheter for 20 days, the luer hub of the distal lumen was found detached.Therefore, the catheter was removed and replaced with a new one.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).The customer returned one 3-l cvc for investigation.Signs of use were observed on the catheter and extension lines.Visual inspection revealed the distal extension line was separated directly adjacent to the luer hub.Remains of the extension line were visible inside the separated distal luer hub.The separation point on the extension line was rough and jagged.The total length of the catheter body measured to be 317 mm which is within the specification of 307mm - 327 mm per product drawing.The outer diameter of the distal lumen measured to be 2.149 mm which is within the specifications of 2.13-2.21 mm per product drawing.The inner diameter of the distal lumen inside the luer hub measured to be 1.4478 mm, which is within the specifications of 1.42-1.50 mm per product drawing.This indicates that the wall thickness measured within specifications.The catheter was functionally tested per the instructions for use (ifu).The ifu provided with this kit instructs the user, "flush each lumen with sterile saline solution, to establish patency and prime lumen(s)." the proximal and medial lumens were flushed using a water-filled lab inventory syringe.The lumens flushed as expected.A manual tug test confirmed the medial and proximal extension lines were fully secured within their respective luer hubs.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with this kit warns the user, "do not apply excessive force in placing or removing catheter.Excessive force can cause catheter breakage.If placement or withdrawal cannot be easily accomplished, an x-ray should be obtained and further consultation requested.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.Open catheter clamp prior to infusion through lumen to reduce risk of damage to extension line from excessive pressure." the report of an extension line/luer hub separation was confirmed through complaint investigation.Visual analysis revealed that the distal extension line had separated adjacent to the luer hub.It was noted that remains of the extension line were found within the luer hub.The medial luer hub was not returned.A capa has previously been initiated due to an increasing trend of cvc extension line leaks and separations.The capa investigation indicated the root cause of this issue is manufacturing related.Corrective actions have not yet been implemented.Teleflex will continue to monitor and trend complaints of this nature.

Event Description

It was reported that, after placement of the catheter for 20 days, the luer hub of the distal lumen was found detached.Therefore, the catheter was removed and replaced with a new one.

• Brand Name: ARROW CVC SET: 3-LUMEN 7FR X 30CM
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC
• 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: 14459709
• MDR Text Key: 292208673
• Report Number: 3006425876-2022-00468
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 04/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: JP-14703-C
• Device Lot Number: 71F21H0725
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/10/2021
• 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