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

Model Number	FT20GN60NSA036N
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient weight was provided as (b)(6) with unknown unit of measurement patient weight was provided as (b)(6) with unknown unit of measurement.
Event or Problem Description
It was reported that the pilot cuff detached from the bivona tracheostomy tube.An emergent trach tube change out was successfully performed as a result.No patient injury or further complications were reported in relation to this event.
Additional Manufacturer Narrative
The balloon portion of the device was not returned by the complainant.Visual inspection of the airway line, which remained attached to the complaint sample showed evidence of damage (reference pictures).Review of the pictures provided by the complainant showed that there was adhesive present to secure the airway line into the balloon and that a portion of the airway line remained seated.The instruction for use, im-gar-10018908-001 (formerly pkg-dfu-cfx-2) states under warnings to guard against product damage by avoiding contact with sharp edges.The investigation did not identify any manufacturing defects, but determined that the airway line was nicked and pulled causing the balloon portion to separate completely from the device.No corrective actions are planned at this time.Smiths medical regularly analyzes complaint data and trends and will take further actions accordingly.
Event or Problem Description
Investigation completed and summarized in h 10.
Additional Manufacturer Narrative
Other text: the sample was received and visual inspection revealed damage.The investigation did not identify any manufacturing defects, but it determined that the airway line was nicked and pulled causing the balloon portion to separate completely from the device.A manufacturing device history review (dhr) was not performed because the lot number was not provided.The root cause was determined to be user interface related.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# (b)(4)., corrected data: d10, h6 and h10.

• Brand Name: BIVONA
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): NULL; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 10587245
• Report Number: 3012307300-2020-09817
• Device Sequence Number: 16454008
• Product Code: JOH
• UDI-Device Identifier: 15019517235029
• UDI-Public: 15019517235029
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/26/2022

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 Model Number: FT20GN60NSA036N
• Device Catalogue Number: FT20GN60NSA036N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/02/2020
• Supplement Date Received by Manufacturer: 11/12/2020; 07/10/2022
• Initial Report FDA Received Date: 09/25/2020
• Supplement Report FDA Received Date: 12/09/2020; 09/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Patient Weight: 57 KG