MAUDE Adverse Event Report: COOK INC THAL-QUICK CHEST TUBE TRAY; GBX CATHETER, IRRIGATION

Catalog Number C-TQTSY-2000

Device Problem Failure to Advance (2524)

Patient Problem No Code Available (3191)

Event Date 03/30/2015

Event Type  Injury  

Manufacturer Narrative

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

Event Description

While inserting the chest tube in a perpendicular direction into the 4th intercostal rib space glancing slightly off the superior border of the rib.The wire passed through the needle with slight amount of friction.The user attempted to pull the needle back over the wire.However the needle did not pass.The user withdrew the entire device enact (wire + needle) from the patient.The user then had to choose an alternate entry point "double-stick" the new chest tube went in without further complication.

• Brand Name: THAL-QUICK CHEST TUBE TRAY
• Type of Device: GBX CATHETER, IRRIGATION
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 6784748
• MDR Text Key: 82376696
• Report Number: 1820334-2017-02410
• Device Sequence Number: 1
• Product Code: GBX
• 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,user f
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 08/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: C-TQTSY-2000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2017
• 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