MAUDE Adverse Event Report: COOK INC; JOH TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	N/A
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/10/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Dolphin bt ciaglia balloon-assisted percutaneous tracheostomy introducer tray with versa tube.(b)(4).Event is still under investigation at this time.
Event or Problem Description
Information was initially provided that the balloon popped.Upon receipt of the product, it was noted that the balloon had burst circumferentially.This did not require intervention and the patient had no adverse consequence.
Additional Manufacturer Narrative
Dolphin bt ciaglia balloon-assisted percutaneous tracheostomy introducer tray with versa tube.Investigation - evaluation: a review of the manufacturing instructions, specifications, drawing, quality control, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed that the balloon had ruptured circumferentially; however, the separated section of the balloon was not returned for examination.Additionally, 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 showed no nonconforming events which could contribute to this failure mode.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be determined.Per the quality engineering risk assessment no further action is required.We will continue to monitor for similar complaints.

• Common Device Name: JOH TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6090037
• Report Number: 1820334-2016-01388
• Device Sequence Number: 16216991
• Product Code: JOH
• UDI-Device Identifier: 00827002555945
• UDI-Public: (01)00827002555945(17)170801(10)6995797
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K093469
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2017

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-PTBSY-2400-VT8
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/14/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/09/2016
• Supplement Report FDA Received Date: 04/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1