MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA TRACHEOSTOMY TUBE, NEONATAL/PEDIATRIC; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Device Problem Device Markings/Labelling Problem (2911)

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

Event Type  malfunction  

Manufacturer Narrative

Udi and 510k are unknown; no additional information was provided.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms #: (b)(4).No lot number was provided; therefore, a device history record (dhr) review could not be completed.Although no product was returned, the investigation was able to be conducted using samples from inventory and printing proofs from the purchasing specification documents.The manufacturing site reviewed the dansk translation on the ped/neo boxes; all four items have silikonetrakeostomitude printed.A sample of instruction for use documents were checked and the word is spelled silikonetrakeostomitube (with the letter b).An email identifying the discrepancy was sent to the graphics labeling supervisor and graphics designer to confirm whether silikonetrakeostomitude was the intended word choice or if there it is a typo since it is only one letter different.The graphics designer acknowledged that the misspelling would be placed on the list for future changes.

Event Description

It was reported that the label on the box was wrong.It was labeled silikonetrakeostomitude, but it should have been labeled silikonetrakeostomitube.No patient injury was reported.

• Brand Name: BIVONA TRACHEOSTOMY TUBE, NEONATAL/PEDIATRIC
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15607000
• MDR Text Key: 307089436
• Report Number: 3012307300-2022-24068
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 10/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1