MAUDE Adverse Event Report: COOK INC WAYNE PNEUMOTHORAX TRAY; DQR CANNULA, CATHETER

Catalog Number C-UTPTY-1400-WAYNE-112497

Device Problem Fitting Problem (2183)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.

Event Description

The following information was reported: the heimlich valve could be inserted the wrong way because it fit on the "wrong" side.It was further noted that the complainant did not think the ifu (instructions for use) for the wayne pneumothorax tray was written clearly.It stated "insert in direction of arrow" and was embossed in clear plastic so it was easily missed.It referred to a connection to a chest drain, but the terminology could have meant the pleurevac or the actual catheter.This product problem did not result in any reported serious injuries to the patient.

• Brand Name: WAYNE PNEUMOTHORAX TRAY
• Type of Device: DQR CANNULA, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 8175745
• MDR Text Key: 131002573
• Report Number: 1820334-2018-03813
• Device Sequence Number: 1
• Product Code: DQR
• 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,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C-UTPTY-1400-WAYNE-112497
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1