MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA ADULT CUFFLESS TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	60A150
Medical Device Problem Codes	Dent in Material (2526); Contamination /Decontamination Problem (2895)
Health Effect - Clinical Codes	Chest Pain (1776); Low Oxygen Saturation (2477)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Other text: b3: date of event is 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 tracheostomy tube has developed issues over one month.Secretions are adhering to its outer surface, an indentation on the tube, and a non-smooth silicone texture that encourages secretion buildup.No injury reported.Chest infection possibly caused by the hard set secretions being on the outer tube.After three days the replacement tube was reviewed.Secretions again found stuck to the side of the outer tube.Under guidance from "us" this was again changed.Again after three days further secretions were found adhered to the outside of the tube.The stoma is red, patient had chest pain, reduced air entry and started treatment for chest infection.Augmentin antibiotics for infection created in lungs.A1: one patient, two product malfunctions.(b)(6) both represent the same patient.This is the second malfunction report for the related complaints.
Additional Manufacturer Narrative
Additional information is provided for h.2 and h.6.No product was returned.If the product is returned this complaint will be reopened for further investigation.Service history review identified the complaint was not related to a previous service of the device within the review period.For all enquiries or follow-up questions related to the record, do not use regulatory.Responses@smiths-medical.Com located in sections g.1., please direct those to the following: regulatory.Responses@icumed.Com.

• Brand Name: BIVONA ADULT CUFFLESS 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: 18006329
• Report Number: 3012307300-2023-09882
• Device Sequence Number: 20495711
• Product Code: JOH
• UDI-Device Identifier: 15021312005547
• UDI-Public: 15021312005547
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K083641
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2024

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: Lay User/Patient
• Device Catalogue Number: 60A150
• Device Lot Number: 4346835
• 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: 09/27/2023
• Supplement Date Received by Manufacturer: 10/30/2023
• Initial Report FDA Received Date: 10/25/2023
• Supplement Report FDA Received Date: 08/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2023
• 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: 21 YR
• Patient Sex: Female
• Patient Weight: 85 KG
• Patient Race: White