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

Catalog Number	60PFSS40
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a routine tape change the mum noticed that the right flange was almost completely broken.This led to an emergency tube change.The tube had first been inserted on (b)(6) 2022.Family had been trying to undertake 28 days with a tube insitu before alternating with a second tube.It had been sterilized 5 times.It was due to be swapped to a new tube.
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
Additional information received via email.There was no patient harm and no medical intervention, but unplanned tube change undertaken to ensure an intact tube was in situ.Patient details updated.Event occurred at patient home.
Additional Manufacturer Narrative
Email is: regulatory.Responses@icumed.Com.One device sample was received 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-conformances 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: 17607947
• Report Number: 3012307300-2023-08364
• Device Sequence Number: 6139117
• Product Code: JOH
• UDI-Device Identifier: 15021312516784
• UDI-Public: 15021312516784
• 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,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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/28/2026
• Device Catalogue Number: 60PFSS40
• Device Lot Number: 4134030
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2023
• Supplement Date Received by Manufacturer: 08/15/2023; 01/23/2024
• Initial Report FDA Received Date: 08/23/2023
• Supplement Report FDA Received Date: 10/30/2023; 02/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 5 YR
• Patient Sex: Unknown