MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX BIVONA TIGHT TO SHAFT SIZE 6; TUBE TRACHEOSTOMY AND TUBE CUFF

Device Problems Tidal Volume Fluctuations (1634); Material Perforation (2205); Gas/Air Leak (2946)

Patient Problems Dyspnea (1816); Tachycardia (2095)

Event Date 10/15/2023

Event Type  Injury  

Manufacturer Narrative

Other, other text: d3, g1, and g2 email is: (b)(4).D4: catalog number, lot number, expiration date, g5: 510k, h4: manufacture date are unknown, no information has been provided on the medwatch.E1: all reporter information is unknown, the reporter asked to remain confidential in the initial medwatch.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 Description

Per medwatch 5147171: "patient noted to have audible leaks and constant low tidal volumes despite inflating cuff and increasing pressures.B 6, rrt and b 6, rrt checked trach cuff integrity and noted a perforated cuff causing a leak and low tidal volumes.Patient had a protex bivona tts 6 after confirmation from rn and md of blown cuff, trach change was performed to (b)(6) via protocols.Patient tolerated well with no complications nor bleeding.No sob or distress noted at that moment.Spo2 100 percent on fio2 50 percent.Trach change done at 2347 on b 6 2023.Patient was admitted back to (b)(6) yesterday b 6 2023 due to events of sob that did not resolve with bagging from his outpatient facility.Patient had a trach that was not the usual trach used at hpmc and requires water to fill the cuff instead of water.Transferred to hpmc for further evaluation.No fever noted.Noted to be tachycardic.Initial reporter asked to remain confidential.".

Manufacturer Narrative

Email is: regulatory.Responses@icumed.Com.No product or photos were returned therefore no device analysis could be completed.A device history record (dhr) review could not be performed as the lot number was unknown.If the product is returned the manufacturer will re-open the complaint for further device analysis.

• Brand Name: PORTEX BIVONA TIGHT TO SHAFT SIZE 6
• Type of Device: 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: reed covert
• MDR Report Key: 18315209
• MDR Text Key: 330329392
• Report Number: 3012307300-2023-11013
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention