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

Model Number	67PFPS40
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2023
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported an issue with some trachs last week.The patient needed trach changes three times in three different shifts due to cuff leaks.The patient's trach must be ordered.The patient once needed a standard length to be placed while waited for more plus lengths to come.The regular length posed no problems.Patient has undergone four separate trach changes and four malfunctioning cuffs in total.Outcome of the event was-resolved.No patient injury was reported.
Additional Manufacturer Narrative
Other, other text: h6.Health impact, and evaluation codes: updated.No product was returned therefore device analysis could not be performed.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.If the device is returned the manufacturer will re-open the complaint for further device analysis.

• Brand Name: SILICONE - BIVONA TUBES NEO/PED FLEXTEND PLUS
• 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: 16234567
• Report Number: 3012307300-2023-00629
• Device Sequence Number: 12363532
• Product Code: JOH
• UDI-Device Identifier: 10351688518545
• UDI-Public: 10351688518545
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/21/2023

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 Model Number: 67PFPS40
• Device Catalogue Number: 67PFPS40
• Device Lot Number: 4334903
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2023
• Supplement Date Received by Manufacturer: 02/16/2023; 07/13/2023
• Initial Report FDA Received Date: 01/24/2023
• Supplement Report FDA Received Date: 03/07/2023; 07/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2022
• 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 Sex: Unknown