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

Catalog Number	FT18BN45NSF878N
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the cuff of a portex® bivona® custom tts¿ tracheostomy tube was difficult to deflate during the time of the patient's first airway change.During removal, the beside respiratory therapist felt a slight resistance.The respiratory therapist initially thought the resistance was due to the patient's "airway issues".Upon looking at the cuff, it was determined the cuff was still inflate with at least 2ml of water.It was stated that the situation was "controlled" and there was no injury to the patient.
Additional Manufacturer Narrative
One tracheostomy tube was returned for analysis in used condition.Functional tests included inflation and deflation testing.The product was inflated and deflated separately with air per inspection procedure along with a leak test, which is how the part is checked during the manufacturing process, and with sterile water, which is how the customer would have used it.In both cases, there were no observable issues, and the product deflated without incident.The device history record was reviewed and no manufacturing or testing issues were found.Based on the evidence, the complaint was unable to be confirmed.The root cause was not able to be determined as the complaint was not confirmed.

• Brand Name: PORTEX® BIVONA® CUSTOM TTS¿ 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: 7419524
• Report Number: 3012307300-2018-01037
• Device Sequence Number: 19241555
• Product Code: JOH
• UDI-Device Identifier: 15019517142747
• UDI-Public: 15019517142747
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2018

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: Respiratory Therapist
• Device Expiration Date: 02/28/2023
• Device Catalogue Number: FT18BN45NSF878N
• Device Lot Number: SS013538
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2018
• Supplement Date Received by Manufacturer: 05/10/2018
• Initial Report FDA Received Date: 04/10/2018
• Supplement Report FDA Received Date: 06/06/2018
• Patient Sequence Number: 1