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

Catalog Number A-6020-08LF

Patient Problem Insufficient Information (4580)

Event Date 10/15/2023

Event Type  malfunction  

Event Description

Initial event severity rating: event reached patient- caused significant harm or required major intervention.Event description: infant had a chest tube with pleural vac attached.The point where the tube entered the pleural vac unit broke off compromising the integrity and sterility of the unit.The chest tube had to be removed and replaced in a critically ill infant on hfov (high frequency oscillatory ventilation) ventilator, nitric oxide, umbilical lines, and pressor drips.New chest tube was inserted by md (doctor).

• 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: 18501981
• MDR Text Key: 332763736
• Report Number: 18501981
• 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: 12/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: A-6020-08LF
• Device Lot Number: 74J2200446
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/22/2023
• Event Location: Hospital
• Date Report to Manufacturer: 01/12/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1