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

Model Number	65SN040
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Hypoventilation (1916)
Date of Event	10/01/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the device was being placed in use with patient.The reporter stated the device obturator could not be removed from the tube.The patient required bag-valve-mask ventilation while this issue was resolved.The tube and obturator were separated and tube was placed without any further adverse effects.
Additional Manufacturer Narrative
Investigation completed on a smiths medical tracheostomy|silicone - bivona tubes neo/ped flextend plus.Two pictures received from p/n 65sn040 l/n unknown, we did not observed damage in the 15mmconnector.Visual inspection: visual inspection did not reveal any damage or substantiate complaint.Results: we visually inspected the sample to see if the assembly meet the half moon specification according to qp bivona tt-fg-tj rev.113.Inspection for bivona finish goods." during the visual inspection, we observed the assembly is within specification.The engineering process prior to release performed goods 100% during testing.The complaint was not confirmed.
Event or Problem Description
Investigation completed and summarized in h 10.

• Brand Name: BIVONA
• Common Device Name: TRACHEOSTOMY TUBE AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• MDR Report Key: 10908847
• Report Number: 3012307300-2020-11790
• Device Sequence Number: 11534111
• Product Code: JOH
• UDI-Device Identifier: 15021312000085
• UDI-Public: 15021312000085
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K944178
• 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): 01/06/2021

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 Model Number: 65SN040
• Device Catalogue Number: 65SN040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/27/2020
• Supplement Date Received by Manufacturer: 12/06/2020
• Initial Report FDA Received Date: 11/26/2020
• Supplement Report FDA Received Date: 01/06/2021
• 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