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

Catalog Number	C-PTISY-100-HC-PERC6
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Brand name: ciaglia blue rhino percutaneous tracheostomy introducer tray with shiley.Investigation: a review of the complaint history, device history record, documentation, quality control, and visual inspection of the returned device was conducted during the investigation.A visual inspection of the returned device found the tray was fully sealed within the larger set.When the set was opened, a flake of foreign matter was see within the tray.A document-based investigation was performed.A review of the device history record of the finished product shows no nonconforming events that could contribute to this failure mode.A complaint history search revealed that there were no other reported complaints for this lot number.Based on this information and quality controls in place, there is no evidence to suggest there are additional non-conforming products in house or in field, and that this is an isolated incident.The root cause of this complaint is manufacturing related, as there was foreign matter in the package that was delivered to the customer.Per the [quality engineering] risk assessment, appropriate personnel have been notified of this finding an no further action is required.Monitoring will continue to be performed for similar complaints.
Event or Problem Description
It was reported a ciaglia blue rhino percutaneous tracheostomy introducer tray with shiley was missing a component.During investigation, an unused/sealed device was returned for evaluation.Foreign matter was found within the sealed sterile tray.

• Brand Name: Ciaglia Blue Rhino
• Common Device Name: JOH TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7906185
• Report Number: 1820334-2018-02792
• Device Sequence Number: 1484321
• Product Code: JOH
• UDI-Device Identifier: 00827002131668
• UDI-Public: (01)00827002131668(17)191001(10)8702757
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 09/25/2018

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 Expiration Date: 10/01/2019
• Device Catalogue Number: C-PTISY-100-HC-PERC6
• Device Lot Number: 8702757
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2018
• Initial Report FDA Received Date: 09/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1