MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX BIVONA FLEXTEND¿ TTS¿TRACHEOSTOMY TUBES; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	60NFPS35
Medical Device Problem Code	Fungus in Device Environment (2316)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/02/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received that during a regular tracheostomy change out, a smiths medical bivona flextend tracheostomy tube was noted to have black mold where the tube connects to the flux.Patient was given antibiotics both orally and through an iv.
Additional Manufacturer Narrative
One tracheostomy was returned for evaluation.Visual inspection of the device has found loose contamination inside the tube and on the connector.The tube was inspected to detect for any black rings inside the tube, and a black ring at the joint between the tube and the connector was observed.Then sample was cut and the wire was taken out to see if the unit has a molded black ring into the tube.No molded black ring was found.The reported customer complaint was confirmed.The reported customer complaint was not confirmed.While no definitive problem source to the reported issue could be determined, this investigation revealed no intrinsic evidence to suggest a root cause related to manufacturing.

• Brand Name: PORTEX BIVONA FLEXTEND¿ TTS¿TRACHEOSTOMY TUBES
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8286689
• Report Number: 3012307300-2019-00421
• Device Sequence Number: 16760261
• Product Code: JOH
• UDI-Device Identifier: 15021312516692
• UDI-Public: 15021312516692
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K944178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2019

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 Expiration Date: 11/19/2021
• Device Catalogue Number: 60NFPS35
• Device Lot Number: 3321729
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2019
• Supplement Date Received by Manufacturer: 04/05/2019
• Initial Report FDA Received Date: 01/29/2019
• Supplement Report FDA Received Date: 05/01/2019
• 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: Life Threatening; Required Intervention
• Patient Age: 20 MO
• Patient Weight: 13