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

Catalog Number	67SN025
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2023
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 during pre-testing the balloon was not inflating.The device was being prepped for a newborn baby.The event did not affect patient care.No injury or adverse effects.
Additional Manufacturer Narrative
One device was received without the original packaging.Per visual inspection, the balloon looked damaged.The complaint was confirmed.Based on the analysis performed on the sample provided, no root cause could be determined and may have been damaged during handling by the end user.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.This issue will continue to be monitored and further actions taken accordingly.

• Brand Name: BIVONA TIGHT TO SHAFT NEONATAL 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: 17647583
• Report Number: 3012307300-2023-08517
• Device Sequence Number: 7212762
• Product Code: JOH
• UDI-Device Identifier: 15021312000238
• UDI-Public: 15021312000238
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K914088
• 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): 10/26/2023

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: Health Professional
• Device Expiration Date: 07/13/2025
• Device Catalogue Number: 67SN025
• Device Lot Number: 4016050
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 08/22/2023
• 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: 08/09/2023
• Supplement Date Received by Manufacturer: 09/30/2023
• Initial Report FDA Received Date: 08/29/2023
• Supplement Report FDA Received Date: 10/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2020
• 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