MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX® BIVONA ¿ TTS¿ NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number	60P055
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/17/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received that a smiths medical tracheostomy was noted to have fungus like substance in the tube.The tracheostomy tube was changed out, and no patient adverse effects resulted.
Additional Manufacturer Narrative
Device evaluation: one portex tracheostomy sample was received for investigation in used condition without its original packaging.Immediate visual inspection found no issues or damage.Next, the returned sample was inflated using a syringe and the product was submerged under water and no leakage or issues were found.To further investigate the issue, relevant documents were reviewed and deemed adequate.Additionally, the cuff assembly operation and inflation line assembly were reviewed with no discrepancies.Inflation tests were audited during thirty two (32) units finding no deflated cuffs.A review of the manufacturing process was also conducted and was considered adequate and correct.Based on the evidence and testing, the complaint allegation was not confirmed.No fault was found with the returned sample.

• Brand Name: PORTEX® BIVONA ¿ TTS¿ NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8446375
• Report Number: 3012307300-2019-01454
• Device Sequence Number: 11209028
• Product Code: BTO
• UDI-Device Identifier: 15021312005783
• UDI-Public: 15021312005783
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K912469
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Catalogue Number: 60P055
• Device Lot Number: 3672616
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2019
• Supplement Date Received by Manufacturer: 03/25/2019
• Initial Report FDA Received Date: 03/22/2019
• Supplement Report FDA Received Date: 09/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention