MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA MID-RANGE AIRE-CUF ADULT TRACHEOSTOMY TUB; TRACHEOSTOMY TUBE AND TUBE CUFF

Model Number	750170
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E4: customer reported to fda is unknown.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No problems or issues were identified during this device history record review.A product sample was received for evaluation.Visual and functional testing were performed.No anomalies were found during the functional test.The root cause of the reported issue could not be confirmed as the reported issue could not be replicated at the time of the device evaluation.No corrective actions were taken since the complaint was not confirmed.
Event or Problem Description
It was reported that there was a respiratory issue.No patient injury was reported.

• Brand Name: BIVONA MID-RANGE AIRE-CUF ADULT 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
• Manufacturer Contact: jim vegel
• MDR Report Key: 16742421
• Report Number: 3012307300-2023-04126
• Device Sequence Number: 5377952
• Product Code: JOH
• UDI-Device Identifier: 15021312006414
• UDI-Public: 15021312006414
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K914088
• 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): 04/14/2023

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 Expiration Date: 06/16/2026
• Device Model Number: 750170
• Device Catalogue Number: 750170
• Device Lot Number: 4136191
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2022
• Initial Report FDA Received Date: 04/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2021
• 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 Age: 48 YR
• Patient Sex: Male
• Patient Weight: 65 KG