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

Model Number	67P035
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample was received for evaluation.A device history record (dhr) review was performed which indicated all inspections were completed and no issues were noted during manufacture.Visual and functional testing were performed and the reported issue could not be confirmed.During visual inspection, no damage to the sample was observed.During functional testing, the sample was found to pass the inflation testing.Manufacturing controls are in place to help prevent occurrence of the reported issue.The root cause of the reported issue could not be determined.No information has been provided to date.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms#: 617147.
Event or Problem Description
It was reported that during pre-testing, only the balloon was found to be inflating.No patient injury was reported.

• 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: 15433242
• Report Number: 3012307300-2022-19330
• Device Sequence Number: 6020389
• Product Code: JOH
• UDI-Device Identifier: 15021312006261
• UDI-Public: 15021312006261
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K944178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• 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: 67P035
• Device Catalogue Number: 67P035
• Device Lot Number: 3907998
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2021
• 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): Yes
• 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