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

Model Number	60NFPS35
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/19/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lot number, expiration date: device manufacture date are unknown, no information has been provided to date.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 right-side flange split on tracheostomy tube.Additional information was received providing more details.The issue was discovered while in use with the patient.The customer was doing the tapes and noticed that the flange had split on the right side.The customer did emergency tube change.Secured new tube and escalated to the ward and what had happened.The customer came and collected a new spare tube and brought in the broken one.This happened when the patient was on home leave for the weekend.There has been no report of observable clinical symptoms or a change in symptoms identified in the patient.
Additional Manufacturer Narrative
Device available for evaluation, h3.Device evaluated by manufacturer and h6.Evaluation codes: updated.D3, g1,2 email is: (b)(6).One device sample was received in used condition without the original packaging.Per visual inspection, it was detected a cut in the flange/neck strap.The complaint was confirmed.No other analysis was performed.A device history record (dhr) review could not be performed as the lot number was unknown.The cause was manufacturing, and the complaint fault has been escalated to address a full root cause investigation and is currently in the investigation phase.

• 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
• Manufacturer Contact: jim vegel
• MDR Report Key: 16576560
• Report Number: 3012307300-2023-02722
• Device Sequence Number: 7150306
• Product Code: JOH
• UDI-Device Identifier: 15021312516692
• UDI-Public: 15021312516692
• 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,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2024

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 Model Number: 60NFPS35
• Device Catalogue Number: 60NFPS35
• 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: 02/28/2023
• Supplement Date Received by Manufacturer: 12/01/2023
• Initial Report FDA Received Date: 03/20/2023
• Supplement Report FDA Received Date: 03/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Age: 10 MO
• Patient Sex: Unknown
• Patient Weight: 8 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American