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

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.(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 the dilator portion of a thal-quick chest tube set broke during a dilation procedure.After the break was identified, the operator opted to use a dilator from a dialysis catheter instead, and was able to complete the drainage procedure successfully.The patient reportedly did not require any additional procedures, and did not experience and adverse events as a result of the issue.The circumstances surrounding the usage and handling of the device are not known.The product was returned; however, as of the date of this report, the investigation is still pending.
Additional Manufacturer Narrative
Additional information: report source.The investigation has been completed.Investigation ¿ evaluation a review of the complaint history, device history record, instructions for use (ifu), manufacturing information, quality control, specifications, and visual inspection of the returned device was conducted during the investigation.The complaint product was returned in a used condition.Visual examination was conducted in our lab.It was noted that the 16.0fr dilator accepted the appropriate size 0.038" wire guide and exited the distal tip appropriately.A further visual examination confirmed the presence of a circumferential split, located near the distal tip portion.The split ran at approximately 3/4 around the diameter of the taper, the split had a range measurement of approximately 1mm from the distal tip up to 3mm.A review of the device history record was reviewed and confirmed that no nonconformances were recorded.Since the c-tqts-1400, thal-quick chest tube set is supplied with component parts, the device history records, ((b)(4)) were reviewed and confirmed there were no recorded nonconformances.There were no other reported complaints for this lot number.The ifu indicates that "upon removal from package, inspect the product to ensure no damage has occurred".It is unknown if this event is associated with a procedurally-related circumstance or due to shipping, handling, and/or storage of the complaint device.Based on the information provided and the results of our investigation, a definitive root cause could not be determined.Per the quality engineering risk assessment, no further action is warranted.Monitoring will continue to be performed for similar complaints.

• 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: 6882062
• Report Number: 1820334-2017-03272
• Device Sequence Number: 1208230
• Product Code: GBX
• UDI-Device Identifier: 00827002057777
• UDI-Public: (01)00827002057777(17)200221(10)7695736
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2017

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: 08/25/2017
• Supplement Date Received by Manufacturer: 11/21/2017
• Initial Report FDA Received Date: 09/21/2017
• Supplement Report FDA Received Date: 12/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1