MAUDE Adverse Event Report: COOK, INC. WAYNE PNEUMOTHORAX SET; CANNULA, CATHETER

Catalog Number C-UTPT-1400-WAYNE-112497

Device Problem Fitting Problem (2183)

Patient Problem Pneumothorax (2012)

Event Date 08/26/2014

Event Type  Injury  

Event Description

Pt had just received a wayne chest tube for treatment of a pneumothorax.While the pt was still in the er, his heimlich valve fell off the chest tube.A nurse placed it back on; however, she placed it backwards and no one noticed.The pt developed a second pneumothorax and had to have another chest tube put in.Pt is ok now.Info was provided on the returned complaint form that the product was in place when event occurred but it was the fault of the staff member to connecting the heimlich valve backwards.Per info provided by the initial reporter, the pt did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

(b)(4).Event is under investigation.

• Brand Name: WAYNE PNEUMOTHORAX SET
• Type of Device: CANNULA, CATHETER
• Manufacturer (Section D): COOK, INC.; bloomington IN 47404
• Manufacturer Contact: rita harden, dir ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4193811
• MDR Text Key: 5146736
• Report Number: 1820334-2014-00524
• Device Sequence Number: 1
• Product Code: DQR
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 09/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: C-UTPT-1400-WAYNE-112497
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/26/2014
• Event Location: Hospital
• Date Manufacturer Received: 09/26/2014
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention