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

Model Number	N/A
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
The international customer reported that, during a chest drain insertion procedure, the operator of the device checked the tip of the dilator contained in the thal-quick chest tube set and discovered that the distal tip of the device was snapped.The operator performed the check by tapping the tip with their finger.The tip had not disengaged, but there was a crack which ran the circumference of the dilator.The broken dilator was retained, another set was opened, and the procedure continued.The product is reportedly available to be returned; however, as of the date of this report, no product has yet been received for evaluation.The dilator did not come into contact with the patient; accordingly, no patient adverse events were experienced.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, device history record, drawing, instructions for use, manufacturing instructions, and quality control data was conducted during the investigation.Visual inspection of the returned device was performed.No damage was noted on the surface of the dilator and a 0.038¿ wire guide was able to be inserted into the dilator with no issue.A 3cm circumferential split was found 2.5mm from the distal tip.A document-based investigation evaluation showed no evidence to suggest the product was not made to specifications.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.Per the instructions for use: ¿upon removal from package, inspect the product to ensure no damage has occurred.¿ based on the provided information, inspection of returned product, and the investigation, a definitive root cause cannot be established or reported at this time.We will notify the appropriate personnel and 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: 6894592
• Report Number: 1820334-2017-03433
• Device Sequence Number: 496586
• Product Code: GBX
• UDI-Device Identifier: 00827002057777
• UDI-Public: (01)00827002057777(17)200212(10)7669209
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2017

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: C-TQTS-1400
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/11/2017
• Supplement Date Received by Manufacturer: 10/19/2017
• Initial Report FDA Received Date: 09/26/2017
• Supplement Report FDA Received Date: 11/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR