MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX® BIVONA® CUSTOM TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	FP17EN40NSE883N
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer has not returned the device to the manufacturer for device evaluation.If the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.
Event or Problem Description
It was reported that the cuff valve of a portex® bivona® custom tracheostomy tube was faulty.The cuff consistently would not deflate.The device was never placed in the patient due to the fault.There was no patient involvement.
Additional Manufacturer Narrative
One used customized tracheostomy tube was received for evaluation.Functional testing was performed in order to detect possible leakage.Upon leak testing, the inflation and deflation process was consistent with what is expected from aire-cuf products.The testing was performed successfully, and no occlusion or leakage was detected.This investigation noted that this is the first time this end user ordered this type of device.It is possible that the end user expected a deflation similar to that of a tight-to-shaft (tts) product.Tight-to-shaft (tts) product cuffs contract completely to the diameter of the shaft; whereas, the cuff of this aire-cuf tracheostomy tube is not indented to contract completely to the diameter of the shaft.The device functioned as intended.A review of the device history record was performed, and no discrepancies were found.While no definitive root cause to the reported issue could be determined, this investigation revealed no intrinsic evidence to suggest a root cause related to manufacturing.

• Brand Name: PORTEX® BIVONA® CUSTOM TRACHEOSTOMY TUBE
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 6711918
• Report Number: 3012307300-2017-01480
• Device Sequence Number: 16660299
• Product Code: JOH
• UDI-Device Identifier: 15019517107647
• UDI-Public: 15019517107647
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2017

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: No Information
• Device Expiration Date: 05/24/2017
• Device Catalogue Number: FP17EN40NSE883N
• Device Lot Number: SS008363
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2017
• Supplement Date Received by Manufacturer: 09/08/2017
• Initial Report FDA Received Date: 07/13/2017
• Supplement Report FDA Received Date: 09/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1