MAUDE Adverse Event Report: COOK INC CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET WITH VERSA TUBE; JOH TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	N/A
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	Respiratory Failure (2484)
Date of Event	08/14/2017
Type of Reportable Event	Serious Injury
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
It was reported by the international customer that, following a tracheostomy procedure with a ciaglia blue rhino percutaneous tracheostomy introducer set with versa tube, a piece of the inner cannula detached.This resulted in respiratory insufficiency in the patient.The inner cannula had to be changed out.The product is available for return.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is previously submitted, unknown, or unavailable.Investigation ¿ evaluation: a review of the complaint history, device history record, documentation, drawing, instructions for use (ifu), manufacturing instructions, quality control, specifications, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed that the outside surface was marred, representing a thin layer of the material separating from the surface.Additionally, a thin layer within the inside diameter of the tube appeared to be separating as well.This was discovered bunched up approximately 2.5 cm from the distal tip of the tube.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.It should be noted there were no other reported complaints for this lot number.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.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.

• Brand Name: CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET WITH VERSA TUBE
• Common Device Name: JOH TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6835823
• Report Number: 1820334-2017-02737
• Device Sequence Number: 13631201
• Product Code: JOH
• UDI-Device Identifier: 00827002556508
• UDI-Public: (01)00827002556508(17)200324(10)7775047
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K133597
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: C-PTIS-350-HC-G-VT7
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/17/2017
• Supplement Date Received by Manufacturer: 02/15/2018
• Initial Report FDA Received Date: 08/31/2017
• Supplement Report FDA Received Date: 02/15/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention