MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA NEONATAL AND PEDIATRIC TTS (TIGHT-TO-SHAFT); TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	67P030
Medical Device Problem Codes	Inflation Problem (1310); Nonstandard Device (1420)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	07/27/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient arrived to unit with a cuffless tracheostomy tube.Significant leakage was occurring while on the ventilator.Prior changing the patient to a cuffed tube, the balloon was assessed for proper inflation.Two cuffed tracheostomy tubes inflated unilaterally.Eventually, the patient's tracheostomy tube was upsized; it properly inflated.Additional information received via customer response email 19-oct-2022: there were 2 separate incidents / patients.
Additional Manufacturer Narrative
Investigation 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.
Additional Manufacturer Narrative
Event problem and evaluation codes: updates not required.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.
Event or Problem Description
Additional information received via customer response email (b)(6) 2022: no patient harm.Excessive leak with cuffless trach, changed out to cuffed trach, issues with cuff inflation and changed out again.Resolved after trach changes.
Additional Manufacturer Narrative
A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.Three product samples were received for evaluation.Visual and functional testing were performed.Samples were visually inspected under normal conditions of illumination and complaint was not confirmed.During the functional inspection, cuff for three samples was inflated successfully, complaint was not confirmed.The root cause of the reported issue was not able to be determined.No corrective action was taken since the complaint was not confirmed.

• Brand Name: BIVONA NEONATAL AND PEDIATRIC TTS (TIGHT-TO-SHAFT)
• 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: 15739347
• Report Number: 3012307300-2022-26791
• Device Sequence Number: 6364437
• Product Code: JOH
• UDI-Device Identifier: 15021312006254
• UDI-Public: 15021312006254
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K944178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/06/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/16/2026
• Device Model Number: 67P030
• Device Catalogue Number: 67P030
• Device Lot Number: 4125827
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 10/17/2022
• Supplement Date Received by Manufacturer: 11/10/2022; 01/26/2023
• Initial Report FDA Received Date: 11/04/2022
• Supplement Report FDA Received Date: 12/07/2022; 02/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2021
• 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: 2 YR
• Patient Sex: Unknown
• Patient Weight: 10 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American