MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA; TRACHEOSTOMY

Model Number	7.0MM
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation completed on a smiths medical tracheostomy|silicone - bivona tubes adult hyperflex tts.The complaint cuff leaking was confirmed when leak procedure wi-10-012, 15cc of air was applied to the device and a slow leak detected on cuff.Validated using magnification a hole was found near he proximal end of cuff with photo attached.Two cuffs were reported leaking with only one device returned.The manufacturing revealed all device passed at 100% prior to release.Complaint revealed leak, unknown cause of event.
Event or Problem Description
Information received a smiths medical tracheostomy|silicone - bivona tubes adult hyperflex tts tube leaked after two days in use.A second cuff was inserted and after two days in use the second cuff was inserted leaked again.No patient adverse events reported.

• Brand Name: BIVONA
• Common Device Name: TRACHEOSTOMY
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• MDR Report Key: 11098798
• Report Number: 3012307300-2020-12877
• Device Sequence Number: 858423
• Product Code: JOH
• UDI-Device Identifier: 15021312013801
• UDI-Public: 15021312013801
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K081440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/31/2020

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: Health Professional
• Device Expiration Date: 03/25/2025
• Device Model Number: 7.0MM
• Device Catalogue Number: 67HA70
• Device Lot Number: 3939458
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2020
• Initial Report FDA Received Date: 12/30/2020
• 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