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

Model Number	HT18DS50NSB928N
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/25/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a smiths medical trach tube was inserted in august and was fine at first but developed a slow leak.The vent kept alarming for a leak for about a week.Around this time, the patient started to experience bleeding around the trach area.Patients mother is unsure if this is related to the issues but patient is still bleeding and two more cuffs experienced pin hole leaks.No further adverse patient effects were reported.
Additional Manufacturer Narrative
Corrected data: phi information: initials (b)(6).Dob (b)(6) 2004.Weight 71 lbs.
Additional Manufacturer Narrative
Other text: a device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.No product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed.If the product is returned, the manufacturer will reopen this complaint for further investigation.D5 is the patient/consumer., corrected data: updated (b1, b2, h1).

• 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: 12713052
• Report Number: 3012307300-2021-10395
• Device Sequence Number: 4775477
• Product Code: JOH
• UDI-Device Identifier: 15019517147735
• UDI-Public: 15019517147735
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,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: 11/04/2021; 09/19/2022
• Initial Report FDA Received Date: 10/28/2021
• Supplement Report FDA Received Date: 12/03/2021; 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): No
• 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
• Patient Age: 17 YR
• Patient Sex: Unknown