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

Catalog Number	67PFSS40
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient was decompensating and needed a trach exchange.A new trach tube was opened.Pre-testing inflation of the cuff was completed to ensure it was not compromised.The cuff, however, only inflated on one side.Another trach package was opened.Subsequent check ascertained effectiveness of new trach.Adverse effects have not been reported.
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.
Additional Manufacturer Narrative
Other text: additional information is provided in h.2., and h.6.No product or photographic evidence were provided to aid in this investigation.The complaint report offered insufficient details to determine whether this product functioned as intended or was used in a manner consistent with its instructions for use (ifu) or failed to meet product specifications.Lacking any additional evidence, this complaint has been closed as unconfirmed.If the product is returned, icu medical will reopen this complaint for further investigation.A device history (dhr) review was performed subsequent to the manufacturing of the device and prior to its release.No problems or issues were identified during this dhr review.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 FLEXTEND PEDIATRIC 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: 17761383
• Report Number: 3012307300-2023-08977
• Device Sequence Number: 15119433
• Product Code: JOH
• UDI-Device Identifier: 10351688518699
• UDI-Public: 10351688518699
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2024

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: Health Professional
• Device Catalogue Number: 67PFSS40
• Device Lot Number: 4334951
• 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: 08/24/2023
• Supplement Date Received by Manufacturer: 04/01/2024
• Initial Report FDA Received Date: 09/15/2023
• Supplement Report FDA Received Date: 04/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2022
• 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