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

Model Number	FT21CN40NSC156N
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Respiratory Insufficiency (4462); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No product was returned.We are unable to confirm the reported complaint.If the product is returned, smiths medical will reopen this complaint for further investigation.
Event or Problem Description
It was reported that a round disk in front of neck flange is causing respiratory distress for child.This was resolved by inserting a stock trach.This happened twice.Upon follow up, it was found that the neck flange configuration of c was selected on the template in error.No patient injury was reported.
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 has been returned for investigation.Based on the complaint details, the wrong neck flange was selected on the submitted template, and manufacturing built the device as specified on the template.

• Brand Name: BIVONA TRACHEOSTOMY TUBES
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 13510079
• Report Number: 3012307300-2022-03177
• Device Sequence Number: 5396932
• Product Code: JOH
• UDI-Device Identifier: 15019517262421
• UDI-Public: 15019517262421
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2022

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: Health Professional
• Device Expiration Date: 06/16/2026
• Device Model Number: FT21CN40NSC156N
• Device Catalogue Number: FT21CN40NSC156N
• Device Lot Number: GA019239
• Was Device Available for Evaluation?: No
• 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: 09/08/2021
• Supplement Date Received by Manufacturer: 08/09/2022
• Initial Report FDA Received Date: 02/10/2022
• Supplement Report FDA Received Date: 09/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2021
• 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 Sex: Unknown