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

Model Number	60PFP60
Medical Device Problem Codes	Break (1069); Defective Device (2588)
Health Effect - Clinical Code	Decreased Respiratory Rate (2485)
Date of Event	07/07/2022
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported the tracheostomy in question broke, the cannula came away from the adaptor where it meets the outer cannula ? an emergency tracheostomy change had to be performed but no harm was done.Once the emergency trache change was done, no other intervention/treatment was required and the issues was resolved.
Additional Manufacturer Narrative
Two (2) photos were attached to the complaint created.Photos showed a tube detached from connector.No other analysis was performed.Based on the analysis conducted in the sample provided, the failure mode reported was confirmed, and the occurrence of this failure condition could be caused by mishandling of the device during unload.The root cause was traced to manufacturing.For corrective action, a customer complaint notification was made to production personnel to explain the importance of following or adhering to the manufacturing procedure.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: 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; crown way; minneapolis, MN 55442
• MDR Report Key: 15716977
• Report Number: 3012307300-2022-26641
• Device Sequence Number: 4897292
• Product Code: JOH
• UDI-Device Identifier: 15021312516821
• UDI-Public: 15021312516821
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K944178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2023

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: 05/18/2025
• Device Model Number: 60PFP60
• Device Catalogue Number: 60PFP60
• Device Lot Number: 3982663
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2022
• Supplement Date Received by Manufacturer: 01/19/2023
• Initial Report FDA Received Date: 11/02/2022
• Supplement Report FDA Received Date: 06/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2020
• 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