MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA FLEXTEND PEDIATRIC AND NEONATAL TRACH TUBE; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number	67NFPS35
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2023
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 upon inspection of new trach, the balloon failed to inflate prior to insertion.Trach was not used on patient.
Additional Manufacturer Narrative
Device evaluated by manufacturer and h6.Evaluation codes: updated.Email is: (b)(6).One device sample was received without the original packaging.Per visual inspection, it was not detected any issue that would cause the cuff to not inflate.The device was inflated with air with the help of a syringe to replicate the reported failure mode.The balloon inflated.The complaint was not confirmed.A device history record (dhr) review reported no discrepancies or non-conformance's during the manufacturing of the reported lot number.No action was taken because the complaint was not confirmed.

• Brand Name: BIVONA FLEXTEND PEDIATRIC AND NEONATAL TRACH TUBE
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• 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: 18195019
• Report Number: 3012307300-2023-10771
• Device Sequence Number: 6439823
• Product Code: JOH
• UDI-Device Identifier: 10351688518798
• UDI-Public: 10351688518798
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2024

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 Catalogue Number: 67NFPS35
• Device Lot Number: 4240122
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 11/09/2023
• 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: 11/03/2023
• Supplement Date Received by Manufacturer: 01/23/2024
• Initial Report FDA Received Date: 11/22/2023
• Supplement Report FDA Received Date: 02/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2022
• 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