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

Model Number	N/A
Medical Device Problem Code	Folded (2630)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
The customer reported that when the ciaglia blue rhino percutaneous tracheostomy introducer was initially placed onto the sterile field, the device was inspected and found to be intact.During placement the device had folded and was malformed in shape.It was only during insertion that the product problem was noted.A new product was opened and inserted successfully, and placed without difficulty.The customer confirmed that no adverse events resulted from the product problem, and no additional procedures were necessitated.The device is reportedly unavailable for return and evaluation as it was noted to have been thrown away.
Additional Manufacturer Narrative
Additional information: after further review of the record, it was determined that it should be noted that it was clarified (07mar2018) that the component related to the event was the shiley trach tube cannula contained in the tracheostomy introducer tray.It was also determined that it should be noted that per the customer, there was difficulty with insertion of the trach when the event occurred.Investigation - evaluation: a review of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, quality control, and specifications of the device was conducted during the investigation.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 were no other reported complaints for this lot number.Ifu states: precautions bronchoscopic guidance is strongly recommended during placement of this device to reduce the likelihood of paratracheal insertion and to determine the intratracheal position of the needle, wire guide, dilators, and tracheostomy tube.Tracheostomy tube should fit snugly to the loading dilator for insertion.The generous lubrication of the loading dilator surface will enhance fit and placement of the tracheostomy tube.Loading dilators are designed to be inserted within a tracheostomy tube only.Tracheostomy tube position should be verified by a chest x-ray.Instructions for use: patient preparation: generously lubricate the surface of the appropriately sized loading dilator and load the tracheostomy tube onto the dilator.Ensure that the tracheostomy tube¿s tip fit snugly on the dilator.Ensure that the balloon is completely deflated.Thoroughly lubricate tracheostomy tube assembly.Tracheostomy procedure: advance the tracheostomy tube (loaded on the dilator) over the wire guide/guiding catheter assembly to the safety ridge of the guiding catheter, then advance wire guide, guiding catheter, loading dilator, and tracheostomy tube as a unit into trachea.Note: the assembly should be directed perpendicular to the axis of the trachea during insertion for uniform dilation between tracheal cartilages.Once the tracheostomy tube is within the tracheal lumen, the assembly may be directed caudad.Note: proper positioning and alignment may help minimize complications (e.G.Stenosis).Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints and have notified the proper personnel about this event.Per the quality engineering risk assessment no further action is required.

• Brand Name: CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY WITH SHILEY
• Common Device Name: JOH TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7284386
• Report Number: 1820334-2018-00372
• Device Sequence Number: 16405007
• Product Code: JOH
• UDI-Device Identifier: 00827002125650
• UDI-Public: (01)00827002125650(17)190101(10)8114254
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K133597
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2018

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-PTISY-100-HC-PERC8
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/30/2018
• Supplement Date Received by Manufacturer: 07/09/2018
• Initial Report FDA Received Date: 02/20/2018
• Supplement Report FDA Received Date: 07/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1