MAUDE Adverse Event Report: TELEFLEX INCORPORATED PLEUR-EVAC; BOTTLE, COLLECTION, VACUUM

Catalog Number A-6000-08LF

Device Problems Leak/Splash (1354); Decrease in Pressure (1490)

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

Event Date 10/10/2022

Event Type  malfunction  

Event Description

Pleur-evac device on chest tube failed to hold pressure on the red/blue connection.Resulted in an air leak in chest tubes.

• Brand Name: PLEUR-EVAC
• Type of Device: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): TELEFLEX INCORPORATED; 3015 carrington mill blvd; morrisville NC 27560
• MDR Report Key: 15730946
• MDR Text Key: 303058636
• Report Number: 15730946
• Device Sequence Number: 1
• Product Code: KDQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/21/2022

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 Catalogue Number: A-6000-08LF
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/21/2022
• Event Location: Hospital
• Date Report to Manufacturer: 11/04/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/04/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 22630 DA
• Patient Sex: Male