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

Model Number	HT18DS50NSB928N
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Codes	Low Oxygen Saturation (2477); Insufficient Information (4580)
Date of Event	08/25/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that trach was inserted in august and was fine at first but developed a slow leak.Another trach that was available was checked before insertion and was found to have a leak but due to them not having any more backup trachs, this one was inserted into the patient while they await backup.No adverse patient effects were reported.
Additional Manufacturer Narrative
Other, other text: there were no non-conforming reports (ncrs) initiated for the lot or anomalies identified in the device history record review.D5 is patient/consumer.Patient information was updated.(a2 and a4), corrected data: updated - b1, b2, g5, h1, h5, h6.

• Brand Name: BIVONA
• Common Device Name: TRACHEOSTOMY TUBE
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• Manufacturer (Section G): NULL; 5700 west 23rd ave; gary IN 46406
• Manufacturer Contact: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 12713269
• Report Number: 3012307300-2021-10401
• Device Sequence Number: 12202992
• Product Code: JOH
• UDI-Device Identifier: 15019517147735
• UDI-Public: 15019517147735
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2022

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: Lay User/Patient
• Device Expiration Date: 09/21/2026
• Device Model Number: HT18DS50NSB928N
• Device Catalogue Number: HT18DS50NSB928N
• Device Lot Number: ST007725
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2021
• Supplement Date Received by Manufacturer: 09/19/2022
• Initial Report FDA Received Date: 10/28/2021
• Supplement Report FDA Received Date: 10/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 16 YR
• Patient Sex: Unknown
• Patient Weight: 32 KG