MAUDE Adverse Event Report: COOK INC UNKNOWN

Model Number N/A

Device Problem Gas/Air Leak (2946)

Patient Problem Pain (1994)

Event Type  malfunction  

Manufacturer Narrative

Date of event: event occurred in 2019 or 2020.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported that the both ends of an unknown chest drain valve were not sealed following a pneumothorax procedure.The patient noted that bubbles were observed in the valve of the drain, "indicating that the procedure was not working." this went on for four days.The physician told the patient that if the bubbles did not stop, they would require open lung surgery.On the fourth or fifth day, the patient was holding the valve and somehow pushed the two ends of the valve back into the device.A snapping sound was made and the bubbling in the valve stopped.The patient was told that, " the bubbles were the result of the faulty valve letting air into his lungs and that he would not need the surgery." the device and securement adhesive were able to be removed within an hour and the patient was sent home.Additional information regarding event and device details have been requested, but are currently unavailable.

Manufacturer Narrative

This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

After review it was determined that this event is not longer reportable under fda 21 cfr part 803, as it does not meet the criteria for a death, serious injury or reportable product malfunction.There is no indication of this malfunction leading to an adverse event.This will be the final report submitted for this occurrence.

• Brand Name: UNKNOWN
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 12468427
• MDR Text Key: 272488180
• Report Number: 1820334-2021-02154
• Device Sequence Number: 1
• Product Code: KDQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 40 YR