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

Model Number	ST15CN65NSC323N
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other text: b3: date of event is unknown, no information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when required.
Event or Problem Description
It was reported that when the patient placed the trach, they had to immediately do a trach change due to a blown cuff.This was a brand-new trach when placed.No adverse patient effects were reported by the customer.
Additional Manufacturer Narrative
Other, other text: h6 conclusion codes: updated.Device evaluation: one device was returned for investigation.Visual inspection did not reveal any defects or anomalies.Functional testing found no defects or product failures.The alleged defect could not be confirmed.There were no non-conforming reports (ncrs) initiated for the lot or anomalies identified in the device history review (dhr).Two units were scrapped, and a tightened inspection was performed on the lot.The reported problem could not be confirmed.No corrective actions are planned at this time.

• Brand Name: BIVONA CUSTOMIZED TRACHEOSTOMY TUBE
• 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: 16869218
• Report Number: 3012307300-2023-05066
• Device Sequence Number: 5944523
• Product Code: JOH
• UDI-Device Identifier: 10351688845597
• UDI-Public: 10351688845597
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2023

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: Other
• Device Model Number: ST15CN65NSC323N
• Device Catalogue Number: ST15CN65NSC323N
• Device Lot Number: GB001230
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 05/01/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2023
• Supplement Date Received by Manufacturer: 05/07/2023
• Initial Report FDA Received Date: 05/04/2023
• Supplement Report FDA Received Date: 05/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2022
• 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