MAUDE Adverse Event Report: COOK INC THORACENTESIS SET; GBX CATHETER, IRRIGATION

Model Number	N/A
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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
International customer reports that a patient was undergoing a thoracocentesis procedure.The customer reports that the three-way valve leaked while attempting to withdraw fluid; air bubbles are seen passing in the outflow tubing.There are no reported adverse patient consequences.The device will not be returned for evaluation.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a review of the complaint history, device history record, documentation, drawing, and quality control of the device was conducted during the investigation, and no issues were found related to the reported issue.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 was one other reported complaint 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.However, appropriate measures have been initiated to address this failure mode.Per the quality engineering risk assessment, no further action is required.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.

• Brand Name: THORACENTESIS SET
• Common Device Name: GBX CATHETER, IRRIGATION
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6750984
• Report Number: 1820334-2017-02190
• Device Sequence Number: 821287
• Product Code: GBX
• UDI-Device Identifier: 00827002032866
• UDI-Public: (01)00827002032866(17)180901(10)NS6126035
• Combination Product (Y/N): N
• Initial Reporter Country: PA
• 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,Followup
• Report Date (Section B): 01/22/2018

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-THS-850
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/11/2017
• Supplement Date Received by Manufacturer: 01/10/2018
• Initial Report FDA Received Date: 07/28/2017
• Supplement Report FDA Received Date: 01/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1