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

Model Number	IPN028442
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	07/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Air leak through pleur-evac when on suction did not resolve with reinforcing dressing around chest tube.Changing pleur-evac resolved the air leak, suggesting the chamber or tubing may have a hole.Postoperative effusion, which was draining well prior to morning of [date redacted], stopped draining well during this period of time.

• Brand Name: PLEUR-EVAC
• Common Device Name: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): TELEFLEX INCORPORATED; 3015 carrington mill blvd.; morrisville NC 27560
• MDR Report Key: 22991971
• Report Number: 22991971
• Device Sequence Number: 8997578
• Product Code: KDQ
• UDI-Device Identifier: 14026704631237
• UDI-Public: (01)14026704631237
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/31/2025
• Report Date (Section F): 07/31/2025

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 Model Number: IPN028442
• Device Catalogue Number: A-6000-08LF
• Device Lot Number: 74D2500649
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/08/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/08/2025
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 07/31/2025