MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX BIVONA CUSTOM 4.0 FLEXTEND TTS TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	FT18KN40NGA122N
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Event date: per reporter, event occurred "weekend of (b)(6)".
Event or Problem Description
Information was received that a patient's smiths medical portex bivona custom 4.0 flextend tts tracheostomy tube pilot balloon leaked approximately five hours after placement.Subsequently, an emergent tracheostomy (trach) change out was required.No adverse patient effects were reported.
Additional Manufacturer Narrative
Evaluation results: one bivona tracheostomy was returned for investigation.The device showed no significant signs of use.A visual inspection under normal plant lighting did not reveal any holes, cuts, tears or other defects.The device was leak tested but failed to remain inflated.A leak was observed in the pilot balloon.The investigation determined that the device did meet manufacturing specification.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.No adverse trends have been identified related to this issue.  no corrective actions are planned at this time.
Event or Problem Description
Information was received indicating that a smiths medical cadd solis vip pump gave "error 45985".No adverse effects were reported.Additional information was received indicating that there was no patient involvement.

• Brand Name: PORTEX BIVONA CUSTOM 4.0 FLEXTEND TTS TRACHEOSTOMY TUBE
• 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: 8360043
• Report Number: 3012307300-2019-00890
• Device Sequence Number: 10808822
• Product Code: JOH
• UDI-Device Identifier: 15019517172904
• UDI-Public: 15019517172904
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2019

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: 12/20/2023
• Device Model Number: FT18KN40NGA122N
• Device Catalogue Number: FT18KN40NGA122N
• Device Lot Number: DS022834
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2019
• Supplement Date Received by Manufacturer: 02/21/2019
• Initial Report FDA Received Date: 02/21/2019
• Supplement Report FDA Received Date: 08/27/2019
• 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
• Patient Age: 1 YR