MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 7 FR X 20 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number CS-25703-E

Device Problem Insufficient Information (3190)

Patient Problem Pneumothorax (2012)

Event Date 03/23/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Physician reported the patient died unrelated to the device or pneumothorax.The customer was unwilling to provide the patient's date of death, cause of death, or relevant medical history.

Event Description

It was reported "the introducer needle was not hard enough to insert subclavian vein".The needle bent towards the lungs and caused a pneumothorax.It was reported the device was replaced.It was unknown if any treatment was provided for the pneumothorax.Additional information was received that the patient had died.The physician reported the pneumothorax was not the cause of death.The patient was well treated for, but other conditions have caused the death.It was reported the pneumothorax had resolved prior to the patient's death.

Manufacturer Narrative

Qn#(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

It was reported "the introducer needle was not hard enough to insert subclavian vein".The needle bent towards the lungs and caused a pneumothorax.It was reported the device was replaced.It was unknown if any treatment was provided for the pneumothorax.Additional information was received that the patient had died.The physician reported the pneumothorax was not the cause of death.The patient was well treated for, but other conditions have caused the death.It was reported the pneumothorax had resolved prior to the patient's death.

• Brand Name: ARROW CVC SET: 3-LUMEN 7 FR X 20 CM
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• 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: 14160757
• MDR Text Key: 289661234
• Report Number: 3006425876-2022-00332
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K900263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/22/2023
• Device Catalogue Number: CS-25703-E
• Device Lot Number: 71F21F2450
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/23/2022
• Initial Date FDA Received: 04/20/2022
• Supplement Dates Manufacturer Received: 05/09/2022
• Supplement Dates FDA Received: 05/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2021
• 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
• Patient Outcome(s): Other