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

Model Number	ST21HN55NSA012S
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the trach would not inflate.The customer confirmed this by pushing air through to the point and thought it might pop.Massaged cuff and it did not help.No patient injury was reported.
Additional Manufacturer Narrative
Date of event: 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 additional reportable information becomes available.
Additional Manufacturer Narrative
Device evaluation: one device received for investigation.Visual inspection found no anomalies.Functional testing showed a majority of the air remained in balloon.When applying pressure to the balloon, a tiny flickering under the cuff at the notched holes was observed.Following the instructions under set up and instructions for use (ifu), the cuff inflated.The device was allowed to rest for four hours.The investigation did not identify a manufacturing defect.There were no non-conforming reports (ncrs) initiated for the lot or anomalies identified in the device history report (dhr).The reported problem could not be confirmed.No corrective actions are planned at this time.

• Brand Name: BIVONA CUSTOMIZED TRACHEOSTOMY TUBES
• 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; 5700 west 23rd ave; gary IN 46406
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis office; minneapolis, MN 55442
• MDR Report Key: 16546213
• Report Number: 3012307300-2023-02477
• Device Sequence Number: 6389152
• Product Code: JOH
• UDI-Device Identifier: 15019517276534
• UDI-Public: 15019517276534
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/17/2023

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: ST21HN55NSA012S
• Device Catalogue Number: ST21HN55NSA012S
• Device Lot Number: GA025034
• 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: 02/21/2023
• Supplement Date Received by Manufacturer: 03/29/2023; 04/11/2023
• Initial Report FDA Received Date: 03/15/2023
• Supplement Report FDA Received Date: 03/30/2023; 04/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2022
• 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 Age: 14 YR
• Patient Sex: Male
• Patient Weight: 52 KG