MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC KIT: 16 GA X 20 CM; CATHETER, PERCUTANEOUS

Catalog Number ASK-04301-KR

Device Problem Fluid/Blood Leak (1250)

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

Event Date 11/17/2022

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).

Event Description

It was reported that blood leaked and wet the gauze after placement of the catheter.Therefore, the catheter was removed and replaced with a new one.No harm to the patient occurred.The physician injected water into the catheter to investigate the cause of the issue, but water did not leak.So, it was unknown what had caused the leak.

Manufacturer Narrative

(b)(4).The customer returned one s-l cvc and the product lidstock for analysis.Signs of use were observed on the returned catheter.Visual inspection of the catheter showed no obvious defects or anomalies.The catheter body length measured 210mm, which is within the specifications of 201.5-210.5mm per product drawing.The catheter outer diameter measured 1.70mm, which is within the specifications of 1.65mm-1.75mm per product drawing.Functional inspection was performed on the returned catheter to recreate the product's intended use.The ifu provided with this kit states: "flush each lumen with sterile saline solution, to establish patency and prime lumen(s)." the catheter was flushed using a lab inventory 10ml syringe.No leaks or blockages were observed.The extension line weas 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 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 extension line.A manual tug test confirmed the extension line was fully secured within its luer hub.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 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 a catheter body leak could not be confirmed by complaint investigation of the returned sample.The returned catheter showed no visual defects or anomalies, and no leaks were observed during functional testing performed according to bs en iso 10555-1 annex c.The catheter passed all relevant dimensional inspection, and a device history record review was performed with no relevant findings.Based on the customer report and the sample returned, no problem was found with the returned sample.Teleflex will continue to monitor and trend for complaints of this nature.

Event Description

It was reported that blood leaked and wet the gauze after placement of the catheter.Therefore, the catheter was removed and replaced with a new one.No harm to the patient occurred.The physician injected water into the catheter to investigate the cause of the issue, but water did not leak.So, it was unknown what had caused the leak.

• Brand Name: ARROW CVC KIT: 16 GA 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: 15986674
• MDR Text Key: 306927934
• Report Number: 3006425876-2022-01094
• 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: 11/24/2022

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 Expiration Date: 06/01/2024
• Device Catalogue Number: ASK-04301-KR
• Device Lot Number: 71F21M2057
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/24/2022
• Initial Date FDA Received: 12/15/2022
• Supplement Dates Manufacturer Received: 01/11/2023
• Supplement Dates FDA Received: 01/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/06/2022
• 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