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

Model Number IPN028446

Device Problem Air/Gas in Device (4062)

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

Event Date 02/20/2023

Event Type  malfunction  

Event Description

The chest tube container was bubbling a large amount when applied to suction even when the tubing to the patient was clamped suggesting air entry into the container.There was no visible damage to the container.The container was changed for a new one and the bubbling slowed significantly.The new container also did not bubble when clamped.Chest tube container in question was sequestered by administrator.

• 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: 16681473
• MDR Text Key: 312705370
• Report Number: 16681473
• 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: Nurse
• Type of Report: Initial
• Report Date: 03/22/2023

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: IPN028446
• Device Catalogue Number: A-7000-08LF
• Device Lot Number: LBL024289R01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/22/2023
• Date Report to Manufacturer: 04/05/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/05/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1