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

Model Number	60PFS45
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a hospital pre-test, the user noticed that the device was labeled as a v flange tracheostomy tube but the product was a straight flange tube.No patient injury was reported.
Additional Manufacturer Narrative
No product or pictures were received to perform an investigation.A device history record (dhr) review confirmed that the device was assembled using a v flange part which was correct according to its bill of materials and labelling.No product was returned, thus the failure mode reported was not confirmed.No root cause could be determined as the complaint could not be confirmed.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# 617147.

• Brand Name: BIVONA UNCUFFED PEDIATRIC FLEXTEND PLUS TRACH 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): 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: 15456456
• Report Number: 3012307300-2022-19805
• Device Sequence Number: 6902445
• Product Code: JOH
• UDI-Device Identifier: 15021312005875
• UDI-Public: 15021312005875
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K944178
• 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
• Report Date (Section B): 09/20/2022

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 Expiration Date: 06/01/2025
• Device Model Number: 60PFS45
• Device Catalogue Number: 60PFS45
• Device Lot Number: 3988103
• 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: 07/07/2022
• Initial Report FDA Received Date: 09/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown