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

Model Number	60P050
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Only the month (b)(6) and year (2021) of the event date are known.Customer facility phone number: (b)(6).Device evaluation in progress.
Event or Problem Description
It was reported that while replacing the neck tape (as part of a daily routine), the operator noticed a crack in the left neck flange.No patient injury or complications were reported in relation to this event.
Additional Manufacturer Narrative
Investigation completed on a smiths medical tracheostomy|silicone - bivona tubes neo/ped.Four pictures received with a cut in the corner of neck strap, which confirmed complaint.Quality takes a representative sample and performs a visual inspection for splits/cuts, exposed wire according to qp bivona tt-fg-tj.Root cause based on the tests performed the failure mode could not be reproduced during molding process.The most probable root cause is that damaged occurred after the product left smiths medical facilities.On section 4.10 states: ?guard against product damage by avoiding contact with sharp edges.Some tracheostomy tube holders contain velcro or metal clips which may have sharp edges.These sharp edges can come into contact with the eyelets and compromise the product integrity.A damaged eyelet can result in decannulation of the tracheostomy tube.We recommend using the twill tape holder supplied with the product.? based on ifu instructions, neckstraps could be damaged by contact with sharp edges from tracheostomy holders.Therefore, it is recommendable use the twill tape holder supplied with the product.
Event or Problem Description
Device evaluation completed and summary.
Additional Manufacturer Narrative
File previously reported as malfunction in error.Type of event updated to serious injury due to requirement of tracheostomy change out.

• 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): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; 7-15-26 fukushima,; minneapolis, MN 55442
• MDR Report Key: 11808881
• Report Number: 3012307300-2021-04208
• Device Sequence Number: 14248562
• Product Code: JOH
• UDI-Device Identifier: 15021312005776
• UDI-Public: 15021312005776
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K912469
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/20/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 60P050
• Device Catalogue Number: 60P050
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 04/19/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/15/2021
• Supplement Date Received by Manufacturer: 07/25/2021; 01/20/2022
• Initial Report FDA Received Date: 05/11/2021
• Supplement Report FDA Received Date: 08/26/2021; 01/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Unknown
• Patient Race: Asian