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

Model Number 67P030

Device Problems Inflation Problem (1310); Nonstandard Device (1420)

Patient Problem Low Oxygen Saturation (2477)

Event Date 07/27/2022

Event Type  Injury  

Event 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.

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.

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 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.

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)
• Type of Device: 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
• MDR Text Key: 303137597
• Report Number: 3012307300-2022-26791
• Device Sequence Number: 1
• Product Code: JOH
• UDI-Device Identifier: 15021312006254
• UDI-Public: 15021312006254
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944178
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 01/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/15/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 2 YR
• Patient Weight: 10 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American