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

Catalog Number	C-TQTS-2000
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/22/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The patient required an additional procedure to replace the device as a result of the product problem.This mdr is being filed after the associated complaint was reviewed under remediation protocol cap008, complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.
Event or Problem Description
The complainant reported that the patient experienced motor agitation (restlessness) and moved a lot.The joint between the drainage catheter and the multi-size connector loosened.The patient required an additional procedure to have the chest tube replaced.

• Brand Name: THAL-QUICK CHEST TUBE SET
• Common Device Name: GBX CATHETER, IRRIGATION
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6800085
• Report Number: 1820334-2017-02653
• Device Sequence Number: 1540416
• Product Code: GBX
• UDI-Device Identifier: 00827002054547
• UDI-Public: (01)00827002054547(17)180730(10)6078821
• Combination Product (Y/N): N
• Initial Reporter Country: SE
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/17/2017

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-TQTS-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: 08/17/2017
• 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
• Patient Age: 75 YR
• Patient Weight: 85