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

Catalog Number	C-TQTSY-2000
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/30/2015
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: GBX CATHETER, IRRIGATION
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6784996
• Report Number: 1820334-2017-02411
• Device Sequence Number: 1247066
• Product Code: GBX
• UDI-Device Identifier: 00827002054639
• UDI-Public: (01)00827002054639(17)171001(10)5692355
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/10/2017

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: C-TQTSY-2000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2017
• Initial Report FDA Received Date: 08/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention