MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA FLEXTEND PEDIATRIC AND NEONATAL TRACH TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	60PFP55
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other, 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 the tracheostomy tube flange and eyelet were torn.Tube was only used twice.Patient was involved.No adverse effects were reported.
Additional Manufacturer Narrative
Device available for evaluation, h3.Device evaluated by manufacturer and h6.Evaluation codes: 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 reported no discrepancies or non-conformance's during the manufacturing of the reported lot number.The cause for the condition was due to manufacturing.The complaint fault has been escalated to address a full root cause investigation for damaged flange/neck strap issues and is currently in the investigation phase.

• Brand Name: BIVONA FLEXTEND PEDIATRIC AND NEONATAL TRACH 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: 17308502
• Report Number: 3012307300-2023-07145
• Device Sequence Number: 15233940
• Product Code: JOH
• UDI-Device Identifier: 15021312014754
• UDI-Public: 15021312014754
• 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: Non-Healthcare 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: 04/08/2026
• Device Model Number: 60PFP55
• Device Catalogue Number: 60PFP55
• Device Lot Number: 4134029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2023
• Supplement Date Received by Manufacturer: 01/23/2024
• Initial Report FDA Received Date: 07/12/2023
• Supplement Report FDA Received Date: 02/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2021
• 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 Age: 6 MO
• Patient Sex: Unknown