MAUDE Adverse Event Report: COOK, INC. COOK; BOTTLE, COLLECTION, VACUUM

Model Number L-CCDV604

Device Problem Defective Device (2588)

Patient Problem Pneumothorax (2012)

Event Date 04/19/2019

Event Type  malfunction  

Event Description

Patient had a right lung biopsy prior to being discharged from the hospital.After the biopsy a chest xray was ordered, the patient was discharged from the hospital prior to the chest xray being read.The xray showed a small pneumothorax.Patient was contacted and came in today for a repeat chest xray.That xray showed a larger pneumothorax and the decision was made to place a chest tube.Patient was admitted through ambulatory surgical unit in order to sedate patient for the procedure.Patient came to interventional radiology (ir) and right chest tube was inserted.Chest tube was attached to heimlich valve.Follow up chest xray showed near 90% pneumothorax.Patient immediately bought to ir by xray tech, dr.Evaluated patient and found heimlich valve was reversed.Heimlich valve was immediately removed and patient was placed on 20 cm of suction.Repeat chest xray showed only 10 % residual pneumothorax.Patient was transferred.Upon investigation, the instructions for the device was on a clear type of paper with print almost impossible to visualize.Both ends of the valve fit into the chest tube.The device should not be able to be reversed.The potential for injury is too great.

• Brand Name: COOK
• Type of Device: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): COOK, INC.; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8572780
• MDR Text Key: 143812914
• Report Number: 8572780
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 04/25/2019

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 Operator: Health Professional
• Device Model Number: L-CCDV604
• Device Catalogue Number: L-CCDV604
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/25/2019
• Event Location: Hospital
• Date Report to Manufacturer: 05/02/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 21170 DA