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

Catalog Number	67PFSS30
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Sample retuned for investigation consist of four parts used for the investigation where it was reported foreign material/contaminate were reported.Investigation performed did not confirm alleged complaint.Embed particulate of parylene were discovered on sample.Root cause was not determined.
Event or Problem Description
It was reported that there were some trachs with filament growths in them.The event occurred at the hospital, there was patient involvement, but no patient harm.
Additional Manufacturer Narrative
H3 and h6.Evaluation codes: updated.Through device analysis embedded particulate of parylene was identified in the samples by visual inspection.A root cause was not identified.A device history record (dhr) review could not be performed as the lot number was unknown.

• Brand Name: BIVONA TRACHEOSTOMY TUBE, NEONATAL/PEDIATRIC
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19704606
• Report Number: 9617604-2024-00565
• Device Sequence Number: 7720083
• Product Code: JOH
• UDI-Device Identifier: 10351688518675
• UDI-Public: (01)10351688518675
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2024

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 Catalogue Number: 67PFSS30
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/03/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2024
• Supplement Date Received by Manufacturer: 07/05/2024
• Initial Report FDA Received Date: 07/09/2024
• Supplement Report FDA Received Date: 07/30/2024
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 5 MO
• Patient Sex: Male
• Patient Weight: 5 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White