MAUDE Adverse Event Report: TELEFLEX INCORPORATED PLEUR-EVAC; APPARATUS, AUTOTRANSFUSION

Device Problem Gas/Air Leak (2946)

Patient Problem Cough (4457)

Event Date 04/12/2022

Event Type  malfunction  

Event Description

Writer noted patient having a large air leak of chest tube when coughing.Writer paged np and came to bedside.Upon assessment, chest tube cannister was found to have malfunctioned and resulted in loss of closed system.Chest tube cannister was replaced and old cannister bagged and saved.Patient stable.

• Brand Name: PLEUR-EVAC
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): TELEFLEX INCORPORATED; 3015 carrington mill blvd; morrisville NC 27560
• MDR Report Key: 15437592
• MDR Text Key: 300052608
• Report Number: 15437592
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/14/2022

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: Lay User/Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/14/2022
• Event Location: Hospital
• Date Report to Manufacturer: 09/16/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/16/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 28470 DA
• Patient Sex: Male
• Patient Weight: 67 KG
• Patient Race: White