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

Model Number	67SN030
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.No lot or serial numbers were communicated; device expiration date and device manufacturing date not available.
Event or Problem Description
It was reported the customer opened a new 3.0 cuffed trach for a routine trach change.Trach cuff would not inflate for inspection prior to usage.Tried both sterile water and air.No patient injury was reported.Additional information received on (b)(6) 2022 via email and attached to complaint object: unknown lot number.
Additional Manufacturer Narrative
Device evaluation : one device was returned for investigation without original packaging.Visual inspection showed no damage.Functional testing was done where the device inflated with gentle manipulation and stayed inflated.No device problem found.No lot number was provided, no device history review able to be done.

• Brand Name: SILICONE - BIVONA TUBES NEO/PED TTS
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• 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: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 16122124
• Report Number: 3012307300-2023-00257
• Device Sequence Number: 6441357
• Product Code: JOH
• UDI-Device Identifier: 15021312000245
• UDI-Public: 15021312000245
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 03/03/2023

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 Model Number: 67SN030
• Device Catalogue Number: 67SN030
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 01/05/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2022
• Supplement Date Received by Manufacturer: 02/15/2023
• Initial Report FDA Received Date: 01/09/2023
• Supplement Report FDA Received Date: 03/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Age: 2 MO
• Patient Sex: Female