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

Catalog Number	FT16LN35NGF124N
Medical Device Problem Codes	Air Leak (1008); Calcified (1077); Leak/Splash (1354); Loose or Intermittent Connection (1371); Component Missing (2306); Failure to Align (2522); Naturally Worn (2988)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/21/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a portex® bivona® tts¿ custom tracheostomy tube was leaking from the cuff.There was no patient injury.
Additional Manufacturer Narrative
One pneupac® parapac® ventilator was received with a battery, oxygen input hose, air input hose, air gas supply indicator shroud ring missing, and eyeball window not correctly in position.Upon visual inspection, damage was noted to the casing and exhalation valve.There was also noted alignment of the peep/ cpap control dial and the detent calibrated mark.Two screws were observed to be loose inside the unit after the unit was opened for further inspection.The screws are reported to hold the gas supply indicator in position.Functional testing was performed and revealed that the relief valve was below specification for different positions (40, 50, 60, & 70).However, noted to not have contributed to the reported fault.Non-return valve assemblies were removed from oscillator block allowing for further investigation finding "swarf" on the non-return valve.The reported swarf was noted to be preventing the valve disc from sealing causing a leak within the unit.Although the reported fault could not be duplicated testing, the observations noted on non-return valve could have initiated a leak causing the increase in inspiratory time, leading to oscillator stall; which could cause the unit to fail.Reason of the swarf is unknown, oscillator block inspected and no further evidence of swarf was noted.Other faults and damages identified would not have contributed towards the reported fault.No adverse trends have been identified relating to the reported issue.

• Brand Name: PORTEX® BIVONA® 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: 7160365
• Report Number: 3012307300-2018-02431
• Device Sequence Number: 19381661
• Product Code: JOH
• UDI-Device Identifier: 15019517090161
• UDI-Public: 15019517090161
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2018

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: 05/10/2023
• Device Catalogue Number: FT16LN35NGF124N
• Device Lot Number: DS016156
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2018
• Supplement Date Received by Manufacturer: 05/25/2018
• Initial Report FDA Received Date: 01/03/2018
• Supplement Report FDA Received Date: 01/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1