MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW THORACENTESIS KIT; CATHETER AND TIP SUCTION

Catalog Number AK-01000

Device Problem Material Separation (1562)

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

Event Date 05/06/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported the doctor was placing the catheter and the catheter detached where it meets the stopcock.The catheter was replaced.No patient harm.The patient's condition is reported as fine.

Manufacturer Narrative

(b)(4).The customer returned one opened thoracentesis kit for analysis.The catheter assembly will be analyzed as part of this complaint investigation.Signs of use in the form of biological material were observed inside the stopcock.Visual analysis revealed that the distal end of the stopcock was separated.A portion of the separated stopcock was still evident within the catheter hub.Microscopic examination confirmed the damage and revealed that the edges of the separation were rough.It was observed that the stopcock was inserted too far into the blue hub.A manual tug test confirmed that the separated portion of the stopcock was secure within the catheter hub.These catheters are assembled using pneumatic cylinders and the stopcock was likely pushed too far into the catheter hub.This in combination with the different material expansion rates and temperature cycling in sterilization and shipping could also contributed to this event.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "some disinfectants used at catheter insertion site contain solvents which can weaken the catheter material.Alcohol, acetone, and polyethylene glycol can weaken the structure of polyurethane materials.These agents may also weaken the adhesive bond between catheter stabilization device and skin." the report that a stopcock cracked/leaked was confirmed through complaint investigation.Visual analysis revealed that the stopcock separated directly adjacent to the proximal opening of the catheter hub.Based on the customer report and the sample received, it was determined that the root cause for this complaint is manufacturing related.A non-conformance was initiated to further investigate this complaint issue.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

It was reported the doctor was placing the catheter and the catheter detached where it meets the stopcock.The catheter was replaced.No patient harm.The patient's condition is reported as fine.

• Brand Name: ARROW THORACENTESIS KIT
• Type of Device: CATHETER AND TIP SUCTION
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 14518405
• MDR Text Key: 292809954
• Report Number: 9680794-2022-00338
• Device Sequence Number: 1
• Product Code: JOL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K870572
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Catalogue Number: AK-01000
• Device Lot Number: 13F21G0953
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2021
• 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