MAUDE Adverse Event Report: CLEARFLOW INC PLEURAFLOW SYSTEM

Model Number PLEURAFLOW SYSTEM

Device Problems Material Puncture/Hole (1504); Torn Material (3024)

Patient Problem Iatrogenic Source (2498)

Event Date 07/13/2015

Event Type  malfunction  

Event Description

Suture entrapment of chest tube resulted in a chest tube tear when it was pulled out & a portion of the chest tube remaining entrapped inside the chest.The original incision was re-opened & the portion of the chest tube was removed from the chest.Procedure was done in the operating room.There was no permanent damage to the patient.This was the result of an iatrogenic source.

• Brand Name: PLEURAFLOW SYSTEM
• Manufacturer (Section D): CLEARFLOW INC; 1630 s sunkist st ste e; anaheim CA 92806
• Manufacturer (Section G): CLEARFLOW INC; 4700 s. overland dr.; tucson AZ 85714
• Manufacturer Contact: 1630 s sunkist st ste e; anaheim, CA 92806
• MDR Report Key: 4996438
• MDR Text Key: 23864208
• Report Number: 3008782989-2015-00001
• Device Sequence Number: 1
• Product Code: OTK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Report Date: 08/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PLEURAFLOW SYSTEM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 47 YR
• Patient Weight: 68