MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA; TRACHEOSTOMY

Model Number	HU17LS60NSB902N
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	Airway Obstruction (1699)
Type of Reportable Event	Malfunction
Event or Problem Description
Information received a smiths medical bivona trach 6.0 cuffless required an emergent trach.Change due to ventilator alarming.Once the trach was changed, the patient was stable.
Event or Problem Description
Device evaluation completed and summary in h 10.
Additional Manufacturer Narrative
Other, other text: this investigation covers complaints related to (b)(4).One device was received by southington for analysis, identified as part # hu17ls60nsb902n.It was confirmed that this part was built in southington based on the part number provided by the complainant.This device was returned due to an emergency trach change after the vent alarm was triggered.There is not a significant amount of information provided about the event which would help determine what prompted the alarm.It is only stated that once the trach was changed, then the vent alarm had stopped.An inspection was preformed on the trach that was sent back, identified as lot number ss030723.As said by the decontamination facility, this was known because the product was sent back in its original packaging.The complainant mentions that the order in question was produced in october, however the lot we have for investigation was produced in august.Upon visual inspection of the trach there is nothing that appears to be of concern.The connector was checked to ensure the attachment of the breathing system would be efficient, pictures are attached to this in.The connector had no signs of damage, the adhesive was acceptable, and the shaft was fully seated.Based on these findings, there is no fault found with the returned device, and therefore no corrective actions are deemed necessary at this time.Smiths-medical truly appreciates all customer feedback, and regularly assesses complaints and post-market data for trends and improvement opportunities.

• Brand Name: BIVONA
• Common Device Name: TRACHEOSTOMY
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• MDR Report Key: 11098801
• Report Number: 3012307300-2020-12887
• Device Sequence Number: 858424
• Product Code: JOH
• UDI-Device Identifier: 15019517135541
• UDI-Public: 15019517135541
• Combination Product (Y/N): N
• PMA/510(K) Number: K923878
• 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): 02/17/2021

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: 01/29/2025
• Device Model Number: HU17LS60NSB902N
• Device Catalogue Number: HU17LS60NSB902N
• Device Lot Number: SS030723
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/04/2020
• Supplement Date Received by Manufacturer: 01/20/2021
• Initial Report FDA Received Date: 12/30/2020
• Supplement Report FDA Received Date: 02/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1