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

Model Number	60PFS45
Medical Device Problem Codes	Fracture (1260); Defective Component (2292)
Health Effect - Clinical Codes	Unspecified Infection (1930); Distress (2329); Decreased Respiratory Rate (2485)
Date of Event	05/25/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was unable to be evaluated as it was not returned.If the device is received in the future an evaluation will be performed.The reported event was unable to be confirmed or replicated.A cause of the reported event could not be determined at this time.
Event or Problem Description
It was reported that the patient was fidgeting, pulling the trach tube and during re-insertion of the trach, it was discovered the trach was broken with a split flange.Additional information received from the customer on 10-jun-2022: the trachy came out as it was not secured due to the flange breaking.The patient's stoma did have some irritation as a result of this incident in addition to some infection as we did not have enough time to change due to the issue not alarming in good time.We had to re-insert, manually hold whilst the new one was prepared.Has had two infections since then.Medical intervention provided- we had to ambu bag the patient.What is the outcome of the product fault: emergency tracheostomy change and unnecessary distress to the child.Resolved.The tube was changed and then noticed the same fault on that one.They had both only been used once.The patient had 3 tube changes within half an hour.Original complaint was (b)(4).
Additional Manufacturer Narrative
Other, other text: a device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.

• Brand Name: BIVONA TRACHEOSTOMY TUBE, NEONATAL/PEDIATRIC
• 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; 5700 west 23rd ave; gary IN 46406
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 14944967
• Report Number: 3012307300-2022-13019
• Device Sequence Number: 6215573
• Product Code: JOH
• UDI-Device Identifier: 15021312005875
• UDI-Public: 15021312005875
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K944178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2022

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: Health Professional
• Device Expiration Date: 06/21/2025
• Device Model Number: 60PFS45
• Device Catalogue Number: 60PFS45
• Device Lot Number: 3991170
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2022
• Supplement Date Received by Manufacturer: 09/23/2022
• Initial Report FDA Received Date: 07/07/2022
• Supplement Report FDA Received Date: 10/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male