MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA NEONATAL/PEDIATRIC TIGHT TO SHAFT TRACHEOST; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	67P040
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2023
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 a new trach tube was used.Problem occurred on test of the balloon prior to patient contact.The balloons of these trachs comes out of the package vacuum sealed.It takes a lot of manipulation to get them free to inflate properly.No patient involvement.No patient or clinical injury.No medical intervention.
Additional Manufacturer Narrative
G2 email is: (b)(4).One device sample was received without the original packaging.Per visual inspection, the pilot balloon was not detached.An inflation test was performed in which the balloon successfully inflated.The complaint was not confirmed.No other analysis was performed.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.No corrective actions were taken because the complaint was not confirmed with the sample provided.

• Brand Name: BIVONA NEONATAL/PEDIATRIC TIGHT TO SHAFT TRACHEOST
• 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: 18048526
• Report Number: 3012307300-2023-10121
• Device Sequence Number: 7468728
• Product Code: JOH
• UDI-Device Identifier: 15021312006278
• UDI-Public: 15021312006278
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K944178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• 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: Other
• Device Expiration Date: 08/03/2024
• Device Catalogue Number: 67P040
• Device Lot Number: 3853388
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 10/10/2023
• Supplement Date Received by Manufacturer: 01/23/2024
• Initial Report FDA Received Date: 11/01/2023
• Supplement Report FDA Received Date: 02/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2019
• 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