MAUDE Adverse Event Report: SMITHS MEDICAL ASD; INC. PORTEX BIVONA NEONATAL AND PEDIATRIC TTS (TIGHT-TO-SHAFT) TRACHEOSTOMY TUBES; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	67SN040
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/24/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received indicating that a patient with a smiths medical portex® bivona® tts¿ (tight-to-shaft) tracheostomy tube was brought to magnetic resonance imaging (mri).It was reported that the patient was grabbing at their throat and the tube had started to come out.Subsequently, the trach was changed out for an mri safe trach and was discarded.The packaging of the tube was noted not to state that the tube was mri "conditional" as the website states it should be.The patient recovered with no adverse effects.
Additional Manufacturer Narrative
Device evaluation: one smiths medical cadd cassette reservoir was returned for analysis in a used condition.During analysis, functional testing was performed, a syringe was used to infuse water into the assembly (ay) bag and leak was detected in the ay bag specifically located on the top corner near pump tube connection.Based on the evidence, the complaint was confirmed, and the problem source of the reported event was noted t be manufacturing.

• Brand Name: PORTEX BIVONA NEONATAL AND PEDIATRIC TTS (TIGHT-TO-SHAFT) TRACHEOSTOMY TUBES
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD; INC.; 6000 nathan lane n; minneapolis, MN 55442
• MDR Report Key: 8238561
• Report Number: 3012307300-2019-00214
• Device Sequence Number: 1928906
• Product Code: JOH
• UDI-Device Identifier: 15021312000269
• UDI-Public: 15021312000269
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K914088
• 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): 03/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Expiration Date: 03/31/2019
• Device Model Number: 67SN040
• Device Catalogue Number: 67SN040
• Device Lot Number: 2643556
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2018
• Supplement Date Received by Manufacturer: 02/17/2020
• Initial Report FDA Received Date: 01/10/2019
• Supplement Report FDA Received Date: 03/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention