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

Model Number	67SP050
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer facility phone: (b)(6).
Event or Problem Description
Information was received indicating that a smiths medical trach was not inflating upon opening the package.There were no reported adverse events.
Additional Manufacturer Narrative
Other, other text: one box and one ifu were returned for analysis.Functional testing could not be performed because tracheostomy tube was not received to be tested per mp bivona tt-tj130 rev.102 ? "leak test" and av-10006853.101 ?leak testing and cuff symmetry visual aid", therefore, the failure mode was not confirmed.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.
Additional Manufacturer Narrative
Other, other text: one box and one ifu were returned for analysis.Functional testing could not be performed because tracheostomy tube was not received to be tested per mp bivona tt-tj130 rev.102 ? "leak test" and av-10006853.101 ?leak testing and cuff symmetry visual aid", therefore, the failure mode was not confirmed.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.
Additional Manufacturer Narrative
Other, other text: corrected data: b1, corrected data: corrected data: b1 - product problem.

• Brand Name: BIVONA
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• Manufacturer (Section G): NULL; 5700 west 23rd ave; gary IN 46406
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 11873720
• Report Number: 3012307300-2021-04946
• Device Sequence Number: 11580556
• Product Code: JOH
• UDI-Device Identifier: 15021312000740
• UDI-Public: 15021312000740
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup,Followup
• Report Date (Section B): 06/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/08/2023
• Device Model Number: 67SP050
• Device Lot Number: 3623102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/26/2021
• Supplement Date Received by Manufacturer: 06/20/2021; 06/20/2021; 06/14/2023
• Initial Report FDA Received Date: 05/24/2021
• Supplement Report FDA Received Date: 07/19/2021; 07/20/2021; 06/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown