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

Model Number	750180
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Deflation Problem (1149); Material Too Soft/Flexible (4007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other text: 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 that the cannula could not be blocked.It was blocked with 12 milliliters (ml) of air to begin with.There was a kink/adhesion on the side of the cuff balloon and the cuff could not be completely blocked properly.After repeated unblocking and blocking, the adhesion came off.However, at 28-30 bar, the cuff and test balloon were very soft and misshapen.In the end, unblocking could not be done completely with a cuff manager.Residual air in the cuff had to be unblocked with a syringe.With the cannula in place, this could have led to severe irritation or even damage to the patient.No injury was reported.
Additional Manufacturer Narrative
Other text: h3 and h6 - evaluation codes: updated.Device evaluation: one device was returned for investigation.Visual inspection found no unusual condition was detected in the sample.No root cause could be determined since the complaint was not confirmed; the sample provided does not show any failure mode.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.No corrective actions are required since the complaint was not confirmed.

• Brand Name: BIVONA TRACHEOSTOMY TUBE, ADULT
• 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
• Manufacturer Contact: jim vegel
• MDR Report Key: 16728337
• Report Number: 3012307300-2023-04054
• Device Sequence Number: 12437583
• Product Code: JOH
• UDI-Device Identifier: 15021312006421
• UDI-Public: 15021312006421
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K083641
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2023

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: 08/17/2025
• Device Model Number: 750180
• Device Catalogue Number: 750180
• Device Lot Number: 4033788
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 04/03/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2023
• Supplement Date Received by Manufacturer: 08/08/2023
• Initial Report FDA Received Date: 04/12/2023
• Supplement Report FDA Received Date: 08/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2020
• 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: Unknown