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

Model Number	N/A
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/14/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
Per the mw(b)(4), reported through the fda voluntary event reporting process, the manufacturer was informed that the guide wire was not removed after chest tube placement.The reporter alleged that the "tag that says "remove dilator after chest tube insertion" is not very noticeable or understandable." it was further reported to the manufacturer in response to inquiry's that: the drainage being performed was pneumothorax, no unintended sections of the device remained in the patient, an additional procedure was performed, the complained device was in place for 1 day, the chest tube was replaced with a different device and remained in for 2 days, the patient is doing well and no adverse events occurred due to this event.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the device history record, manufacturing instructions, quality control, and specifications of the returned device was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• 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: 6110276
• Report Number: 1820334-2016-01337
• Device Sequence Number: 1123628
• Product Code: GBX
• UDI-Device Identifier: 00827002067868
• UDI-Public: (01)00827002067868(17)190330(10)6854808
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: C-TQTS-800
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/25/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/17/2016
• Supplement Report FDA Received Date: 05/09/2017
• 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: 1 DA