MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 7FR X 20CM; CATHETER,INTRAVASCULAR,THERAP

Catalog Number CV-25703-E

Device Problem Insufficient Information (3190)

Patient Problem Pneumothorax (2012)

Event Date 04/30/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Customer reports "(b)(6)-year-old patient, diagnosed with covid 19 infection, who requires passage of a central venous catheter for sedo analgesia and muscle relaxation, during a procedure performed by an internist.Generates tension pneumothorax, which required a thoracotomy to resolve the event.".

Manufacturer Narrative

(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

Customer reports "61-year-old patient, diagnosed with covid 19 infection, who requires passage of a central venous catheter for sedo analgesia and muscle relaxation, during a procedure performed by an internist.Generates tension pneumothorax, which required a thoracotomy to resolve the event.".

• Brand Name: ARROW CVC SET: 3-LUMEN 7FR X 20CM
• Type of Device: CATHETER,INTRAVASCULAR,THERAP
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11992149
• MDR Text Key: 255970308
• Report Number: 3006425876-2021-00530
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K900263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 05/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/10/2022
• Device Catalogue Number: CV-25703-E
• Device Lot Number: 71F20J2440
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR