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

Model Number	670175
Medical Device Problem Code	Unexpected Color (4055)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other, other text: e4 is unknown.No information has been provided to date.H10: device evaluation: two photos were included as attachments for evaluation; one photo showed a stain on the cuff; the complaint was confirmed.Manufacturing process was reviewed to see if there were any blue sources that might stain the samples as result no stain were found in the process.Additional analysis was conducted, which consisted of reviewing the instructions for use that are included in the device, because these instructions contain important information for cleaning and sanitization process.Based on instructions for use (ifu) this device could be stain after the cleaning and sterilization process if the instructions for use are not followed correctly.Based on visual inspection and reviewing of manufacturing process where no sources of contamination were found the most probable root cause is that damaged occurred after product left facilities.Cause traced to use.No corrective actions were taken.A dhr (device history review) was performed subsequent to the manufacturing of the device and prior to its release.No problems or issues were identified during this dhr review.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
Event or Problem Description
It was reported that the user noticed a small discoloration spot after the cuff was inflated.Discovered immediately on use.No injury or clinical consequence observed.

• Brand Name: BIVONA TRACHEOSTOMY TUBE
• 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
• Manufacturer Contact: jim vegel
• MDR Report Key: 17210915
• Report Number: 3012307300-2023-06705
• Device Sequence Number: 6333417
• Product Code: JOH
• UDI-Device Identifier: 15021312006063
• UDI-Public: 15021312006063
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K944178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/27/2023

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: 05/12/2026
• Device Model Number: 670175
• Device Catalogue Number: 670175
• Device Lot Number: 4122532
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2022
• Initial Report FDA Received Date: 06/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown