MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA NEONATAL AND PEDIATRIC TTS TRACHEOSTOMY TUB; TRACHEOSTOMY TUBE AND TUBE CUFF

Model Number	67P050
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the cuff did not inflate properly.No patient involved.
Additional Manufacturer Narrative
One unit was returned for investigation.Upon physical inspection, it was found, that the complained issue could not be duplicated.The device passed all functional tests.Dhr review was done.No issues related to the original complaint were found.
Additional Manufacturer Narrative
Other text: this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).Corrected h6 code - evaluation codes method., corrected data: h6 code - evaluation codes method.

• Brand Name: BIVONA NEONATAL AND PEDIATRIC TTS TRACHEOSTOMY TUB
• Common Device Name: TRACHEOSTOMY TUBE 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: 13195890
• Report Number: 3012307300-2022-00323
• Device Sequence Number: 17638417
• Product Code: JOH
• UDI-Device Identifier: 15021312006292
• UDI-Public: 15021312006292
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K944178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/08/2023

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
• Operator of Device: Health Professional
• Device Model Number: 67P050
• Device Catalogue Number: 67P050
• Device Lot Number: 4086008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2021
• Supplement Date Received by Manufacturer: 04/11/2022; 05/01/2023
• Initial Report FDA Received Date: 01/07/2022
• Supplement Report FDA Received Date: 05/09/2022; 05/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown