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

Model Number IPN028484

Device Problems Backflow (1064); Air/Gas in Device (4062)

Patient Problem Insufficient Information (4580)

Event Date 02/14/2022

Event Type  malfunction  

Event Description

During morning assessment one of patient's chest tubes was noted to have blue water seal fluid that had flowed back into the output chamber.Patient has had numerous pneumothoraces during admission.No crepitus noted.Per report, air leak was present overnight but not since patient was paralyzed at 0600.Per dept.Mgr.: event noted; consulting supply chain for awareness.This is a known issue that was previously a safety alert.This patient has 3 chest tubes in place currently with a possible bronchopleural fistula, and the other 2 chest tubes were functioning correctly.This suction canister is being changed out by the bedside rn.Unclear impact of this canister defect on patient condition, but is at least resulting in the canister needing to be changed that otherwise would not be required at this time.

• 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: 14799466
• MDR Text Key: 294676693
• Report Number: 14799466
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 02/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: IPN028484
• Device Catalogue Number: S-1100-08LF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/14/2022
• Event Location: Hospital
• Date Report to Manufacturer: 06/24/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 6935 DA
• Patient Sex: Male
• Patient Weight: 118 KG
• Patient Race: Black Or African American