MAUDE Adverse Event Report: CAREFUSION 2200, INC. PLEURAL CATHETER SYSTEM; APPARATUS, SUCTION, PATIENT CARE

Catalog Number 50-7000B

Device Problems Product Quality Problem (1506); Obstruction of Flow (2423)

Patient Problem Pneumothorax (2012)

Event Date 08/12/2022

Event Type  Injury  

Event Description

An incident that happened around 5 pm, after surgery regarding a patient.The fellow came to the surgery front desk and informed of an incident.Patient had a tension pneumo following his video assisted thoracotomy with a pleurax placement.A white connector piece from the kit was not patent.He was trouble shooting the system at the patient's bedside of why the catheter was not working properly.When he disassemble the setup, he noticed the piece from the kit was not patent.This piece was immediately removed and changed and then the catheter was working properly.The fellow brought the connector back to the operating room for the surgical services to follow up.I called sicu to check on the patient he was stable and doing well.The lot number of the inserted catheter is 0001471891 we had 2 in the surgical unit that were pulled, and materials management was notified of the lot number to pull and retain all units to swap out for different kits.Fda safety report id# (b)(4).

• Brand Name: PLEURAL CATHETER SYSTEM
• Type of Device: APPARATUS, SUCTION, PATIENT CARE
• Manufacturer (Section D): CAREFUSION 2200, INC.
• MDR Report Key: 15249584
• MDR Text Key: 298339190
• Report Number: MW5111553
• Device Sequence Number: 1
• Product Code: DWM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Catalogue Number: 50-7000B
• Device Lot Number: 0001471891
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 87 YR
• Patient Sex: Male