MAUDE Adverse Event Report: SMITHS MEDICAL ASD,INC. TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	SILICONE - BIVONA TUBES NEO/PED TTS
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	Respiratory Distress Syndrome of Newborns (2046)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No product to be returned.
Event or Problem Description
Information received a smith medical silicone - bivona tubes neo/ped tts would not inflate.The physician reports that was a trach was brought to the bedside for a last resorted effort to ventilate a patient that was in respiratory failure.The patient had a leak in her existing tube that was not a smiths medical product.This was an emergent tracheostomy change that is being described.Three providers were not able to inflate the balloon.Fifteen minutes elapsed and used higher pressure to inflate balloon, which was at risk for rupture.This intervention done by ent team member was successful.The report indicates the patient was high risk for failed respiratory intervention, which would lead to death, as compromised airway, breathing and circulation were described and report is considered serious injury reportable.The device will not be returned for investigation, as the device can not be returned in failed condition according to provider.

• Brand Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• 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: 9629315
• Report Number: 3012307300-2020-00816
• Device Sequence Number: 16836129
• Product Code: JOH
• UDI-Device Identifier: 15021312006261
• UDI-Public: 15021312006261
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K944178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/20/2020

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: Health Professional
• Device Expiration Date: 03/27/2024
• Device Model Number: SILICONE - BIVONA TUBES NEO/PED TTS
• Device Catalogue Number: 67P035
• Device Lot Number: 3802227
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2019
• Initial Report FDA Received Date: 01/24/2020
• 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: Life Threatening; Required Intervention
• Patient Age: 2 YR