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

Catalog Number 670170

Device Problems Labelling, Instructions for Use or Training Problem (1318); Device Markings/Labelling Problem (2911); Missing Information (4053)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Other, other text: b3: date of event is unknown; no information has been provided to date.D3, g1, and g2 email is: regulatory.Responses@icumed.Com.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

It was reported that "during a submission of a tender in denmark, the included instructions for use (ifu) was incomplete and the danish translation was missing.Additionally the translation of the product name contained a typo on the label (reads siliconetrakeostomitude, correct is siliconetrakeostomitube)".

• Brand Name: BIVONA TIGHT TO SHAFT TRACHEOSTOMY TUBE
• 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: 18242014
• MDR Text Key: 330034337
• Report Number: 3012307300-2023-10903
• Device Sequence Number: 1
• Product Code: JOH
• UDI-Device Identifier: 15021312006056
• UDI-Public: 15021312006056
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K083641
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 670170
• Device Lot Number: 4399119
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1