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

Model Number	67P050
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample was not received for investigation.The customer reported issue could not be confirmed due to no receipt of photos of actual sample for investigation.Additionally, the lot number of the reported device was not provided therefore no device history review (dhr) could be performed.Manufacturing controls are in place to help prevent occurrence of the reported issue.No root cause could be determined since no product and/or photos were received to investigate the reported issue.If the product is returned at a later, a summary of the investigation results will be provided in a supplemental report.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 the cuff is inflating asymmetrically during pre-check.No patient involvement.

• Brand Name: BIVONA
• Common Device Name: FLEXTEND PEDIATRIC AND NEONATAL TRACHEOSTOMY TUBE
• 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: 15426901
• Report Number: 3012307300-2022-19233
• Device Sequence Number: 17325683
• Product Code: JOH
• UDI-Device Identifier: 15021312006292
• UDI-Public: 15021312006292
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K944178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/15/2022

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 Model Number: 67P050
• Device Catalogue Number: 67P050
• 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: 07/09/2022
• Initial Report FDA Received Date: 09/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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