MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX BIVONA FLEXTEND NEONATAL AND PEDIATRI; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Model Number	505070
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Received product for investigation without original packaging.No defects or abnormalities detected in visual inspection.The product failed the water leak test.Further investigation using magnification revealed a slight deformity to the end-formed tip and/or the blocking rod area, thus confirming the complaint.The tip of this lumen is blocked to divert the air flow through the inflation line into the cuff.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.Operator of device is unknown.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
Event or Problem Description
It was reported that during device setup, it failed leak test.Balloon would no stay inflated.No patient injury was reported.

• Brand Name: PORTEX BIVONA FLEXTEND NEONATAL AND PEDIATRI
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15438778
• Report Number: 3012307300-2022-19472
• Device Sequence Number: 14871114
• Product Code: BTR
• UDI-Device Identifier: 10351688000231
• UDI-Public: 10351688000231
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K934465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 09/16/2022

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
• Device Expiration Date: 06/30/2025
• Device Model Number: 505070
• Device Catalogue Number: 505070
• Device Lot Number: 4063764
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2022
• Initial Report FDA Received Date: 09/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown