MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. SMITHS MEDICAL SILICONE BIVONA TUBES NEO/PED; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	67SN040
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Codes	Irritability (2421); Low Oxygen Saturation (2477)
Date of Event	09/03/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received that while a smiths medical tracheostomy was in use, patient had low blood oxygen and was irritable.The incident required bagging and increased oxygen.It was reported the patient required a trachoestomy tube change out to sustain life; the patient then recovered.No further adverse effects reported.
Additional Manufacturer Narrative
Device evaluation: returned device was received in good physical condition.During the evaluation of the device the sample was tested on leak test, the unit was inflated, and it was visually inspected for 10 seconds, it wasn't observed any leakage and it was seen well inflated.Then the units were submerged under water, it wasn't observed any leakage.It was followed to massage the product, the balloon was squeezed and the airway line was moved back and forth, no leaks were found.The customer reported condition was not confirmed.No fault found.The device history record was not reviewed.

• Brand Name: SMITHS MEDICAL SILICONE BIVONA TUBES NEO/PED
• 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: 9153128
• Report Number: 3012307300-2019-05282
• Device Sequence Number: 3137407
• Product Code: JOH
• UDI-Device Identifier: 15021312000269
• UDI-Public: 15021312000269
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2020

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 Catalogue Number: 67SN040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2019
• Supplement Date Received by Manufacturer: 12/16/2019
• Initial Report FDA Received Date: 10/03/2019
• Supplement Report FDA Received Date: 01/15/2020
• 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: Other; Required Intervention