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

Model Number	60SP035
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the flange broke leading to a trach change to resolve the issue.
Additional Manufacturer Narrative
Three units were returned for investigation.Upon physical inspection, it was found that the complained issue could not be duplicated.Dhr review was done, no issues related to the original complaint were found., corrected data: lot number were changed to 3911420 and 4056229.
Additional Manufacturer Narrative
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.During the visual inspection, it was observed one flange was broken.The root cause of the reported issue was found to be the most probable root cause was that damaged occurred after the product left the manufacturing facilities.No actions were taken to mitigate the reported issue.

• Brand Name: BIVONA
• 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: 12657954
• Report Number: 3012307300-2021-10085
• Device Sequence Number: 11064692
• Product Code: JOH
• UDI-Device Identifier: 15021312000375
• UDI-Public: 15021312000375
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K912469
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• 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: Lay User/Patient
• Device Expiration Date: 11/15/2024
• Device Model Number: 60SP035
• Device Lot Number: 3911420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2021
• 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: 09/07/2021
• Supplement Date Received by Manufacturer: 10/20/2021; 05/03/2023
• Initial Report FDA Received Date: 10/19/2021
• Supplement Report FDA Received Date: 11/19/2021; 05/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2020
• 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
• Patient Sex: Male