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

Catalog Number	67SP055
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/27/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received indicating that the cuff to a smiths medical portex bivona flextend¿ tts¿ tracheostomy tube was observed to be deflating.The defective trach tubes were reported to be brought in by the respiratory therapist; indicating they had been removed.There was no reported patient harm.
Additional Manufacturer Narrative
One bivona flextend¿ tts¿ tracheostomy tube was returned for analysis in used condition.Wrinkles were found on the cuff with contamination observed on the shaft, cuff and neck strap upon visual inspection.Air was inflated in the cuff with no leaks observed.The trach was leak tested by inflating the cuff and assessing for 10 seconds; no leakage was observed.The unit was then inflated while it was submerged under water; no discrepancies found.The product was then massaged, squeezed and the air line was moved back and forth; no leakage detected.The manufacturing, training and assembly processes were reviewed; no discrepancies.Manufacturing process verification was performed on 32 units; air cuff symmetry was correctly performed.Based on the evidence, there was no found root cause as the complaint was not confirmed.

• Brand Name: PORTEX BIVONA FLEXTEND¿ TTS¿ TRACHEOSTOMY TUBE
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD; INC.; 6000 nathan lane n; minneapolis, MN 55442
• MDR Report Key: 9106919
• Report Number: 3012307300-2019-05030
• Device Sequence Number: 1801017
• Product Code: JOH
• UDI-Device Identifier: 15021312000757
• UDI-Public: 15021312000757
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K914088
• 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): 11/08/2019

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?: Yes
• Operator of Device: No Information
• Device Catalogue Number: 67SP055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2019
• Supplement Date Received by Manufacturer: 10/09/2019
• Initial Report FDA Received Date: 09/23/2019
• Supplement Report FDA Received Date: 11/11/2019
• 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