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

Catalog Number	FT15LN90NSC861N
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Other, 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 patients mother called in stating that "the balloon on the trach was not inflating correctly".The trach was removed and a new trach was placed.No adverse patient effects were reported by the customer.
Additional Manufacturer Narrative
Other, other text: h3.Device evaluated by manufacturer and h6.Evaluation codes: updated.One device without packaging and labeling was returned for analysis.A functional leak test was performed to identify any holes in the cuff area or gaps in adhesive that may have led to the cuff inflation fault reported; however, no leakage or inflation faults were noted during evaluation and was found to be within specification.The complaint was not confirmed.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.No correction or corrective actions conducted at this time.This issue will be monitored, and further actions taken accordingly.

• 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
• Manufacturer Contact: jim vegel
• MDR Report Key: 17966614
• Report Number: 3012307300-2023-09760
• Device Sequence Number: 20537760
• Product Code: JOH
• UDI-Device Identifier: 15019517035322
• UDI-Public: 15019517035322
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: FT15LN90NSC861N
• Device Lot Number: ST017709
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 10/02/2023
• 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: 09/22/2023
• Supplement Date Received by Manufacturer: 10/24/2023
• Initial Report FDA Received Date: 10/19/2023
• Supplement Report FDA Received Date: 11/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown