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

Model Number	60PFS45
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.Product samples were received for evaluation.Visual and functional testing were performed.Two (2) samples were received in new conditions inside their closed original packaging.Visual inspection was performed at 12" under normal lighting to received units.During the visual inspection, it was observed that products inside the trays don't match labelling, labelling is for a product with a v flange and the product inside the tray has a straight flange.The complaint is confirmed.A corrective and preventative action has been opened to address the reported issue and potential root cause.Containment actions were taken place immediately.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
Event or Problem Description
It was reported that two trachs tubes should have a v-flange but both of them were straight.They are sealed and unopened in the packaging still.No patient injury reported.

• Brand Name: BIVONA
• 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: 15410204
• Report Number: 3012307300-2022-18900
• Device Sequence Number: 5620864
• 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: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/13/2022

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: 06/26/2025
• Device Model Number: 60PFS45
• Device Catalogue Number: 60PFS45
• Device Lot Number: 3991171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2022
• Initial Report FDA Received Date: 09/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2020
• 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