MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC KIT: 4-LUMEN 8.5FR X 20CM; CATHETER, PERCUTANEOUS

Catalog Number ASK-15854-KR

Device Problem Obstruction of Flow (2423)

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 05/10/2022

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).

Event Description

It was reported the catheter was inserted through the inguinal area on (b)(6).On (b)(6), the user tried to inject the medical agent through the distal lumen, but failed.The user aspirated with the syringe but that caused a small elevation on the patient's skin around the insertion site.The catheter was removed and replaced.No patient injury was reported.The patient's condition is reported as fine.

Manufacturer Narrative

Qn# (b)(4).The customer returned one 4-l cvc catheter for analysis.Signs of use in the form of biological material were observed in the extension lines.Visual inspection of the distal extension line did not reveal any damage.The inner diameter of the distal lumen measured 1.4224 mm which is within specifications of 1.42-1.50 mm per product drawing.The outer diameter of the medial lumen measured 2.177 mm which is within specifications of 2.13-2.21 mm per product drawing.This indicates that the wall thickness measured within specifications.The total length of the catheter body measured 222 mm which is within specifications of 207-227 mm per catheter product drawing.The extension lines were 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 distal, medial 1, medial 2, and proximal extension lines were flushed using a water-filled lab inventory syringe.All lines flushed as expected.A lab wire was able to pass through the distal lumen with no issues.A manual tug test confirmed the distal , medial 1, medial 2, and proximal extension lines were fully secured within the luer 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 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.Open catheter clamp prior to infusion through lumen to reduce risk of damage to extension line from excessive pressure." the report of a blocked extension line was not able to be confirmed through complaint investigation of the returned sample.The catheter passed all relevant dimensional and functional testing.Based on the sample returned, no problem was found.Teleflex will continue to monitor and trend complaints of this nature.

Event Description

It was reported the catheter was inserted through the inguinal area on (b)(6).On (b)(6), the user tried to inject the medical agent through the distal lumen, but failed.The user aspirated with the syringe but that caused a small elevation on the patient's skin around the insertion site.The catheter was removed and replaced.No patient injury was reported.The patient's condition is reported as fine.

• Brand Name: ARROW CVC KIT: 4-LUMEN 8.5FR X 20CM
• 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: 14574742
• MDR Text Key: 293301878
• Report Number: 3006425876-2022-00501
• Device Sequence Number: 1
• Product Code: DQY
• 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: 05/11/2022

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: ASK-15854-KR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/11/2022
• Initial Date FDA Received: 06/02/2022
• Supplement Dates Manufacturer Received: 06/28/2022
• Supplement Dates FDA Received: 06/28/2022
• 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