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

Model Number	G49507
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/12/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.Blank fields on this form that have not been previously submitted indicate the information is unknown or unavailable.
Event or Problem Description
The complainant reported that a pop sound was heard and saline began to leak from the balloon as soon as the balloon was inflated to 11 atm.The user removed the balloon and used a finger to confirm if adequate dilation was achieved.The procedure continued as intended and was successful.There were no reported adverse effects to the patient as a result of the product problem.

• Brand Name: Dolphin BT
• Common Device Name: JOH TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7374832
• Report Number: 1820334-2018-00888
• Device Sequence Number: 13801097
• Product Code: JOH
• UDI-Device Identifier: 00827002495074
• UDI-Public: (01)00827002495074(17)170901(10)6721080
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/27/2018

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: G49507
• Device Catalogue Number: C-PTBSY-2800-PERC8
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2018
• Initial Report FDA Received Date: 03/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1