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

Model Number	67PFP60
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that ten days after insertion, when the tube was removed by the patient's father for cleaning, it was observed that the tube length appeared to be longer than usual.The cuff did not lay flat against shaft once deflated.No consequence for patient but felt uncomfortable.
Additional Manufacturer Narrative
This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No problems or issues were identified during this device history record review.A product sample was received for evaluation.Visual and functional testing were performed.When the sample was inflated with air, the cuff only inflated one side.The root cause of the reported issue was found to be inflation, leakage, and symmetrical issues.A corrective and preventative action has been opened to address the reported issue.

• Brand Name: BIVONA SILICONE TRACHEOSTOMY TUBE, PEDIATRIC
• 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): NULL; 5700 west 23rd ave; gary IN 46406
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 14249909
• Report Number: 3012307300-2022-07181
• Device Sequence Number: 4159178
• Product Code: JOH
• UDI-Device Identifier: 10351688518538
• UDI-Public: 10351688518538
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2023

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: Lay User/Patient
• Device Expiration Date: 03/25/2026
• Device Model Number: 67PFP60
• Device Catalogue Number: 67PFP60
• Device Lot Number: 4128029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2022
• Supplement Date Received by Manufacturer: 01/05/2023
• Initial Report FDA Received Date: 04/29/2022
• Supplement Report FDA Received Date: 04/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/04/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown