MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA AIRE-CUF NEO/PED TRACHEOSTOMY TUBES; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	65SP040
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One tracheostomy tube was received for evaluation in relation to the reported event.Evaluation of the device is currently in progress.Once the evaluation is complete, a follow-up report with evaluation results will be submitted.
Event or Problem Description
It was reported that ten days after starting to use the product, the customer found a crack in the flange of the tracheostomy tube.There was no patient injury reported.
Additional Manufacturer Narrative
Other, other text: this mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).A product sample was received for evaluation.Visual and functional testing were performed.No problems or issues were identified during this device history record review.One (1) sample was received in used conditions, without its original packaging and with its certificate of safe handling.The sample was visually inspected at a distance of 12 inches under normal lighting for received unit.Sample was visually inspected in following components.According with visual inspection, condition reported in complaint was visible, however, this does not assure us that there was still a failure of the process.Mishandling by the user by not adjusting the tracheostomy device correctly could cause the rupture after ten days of use.Based on this the failure mode cannot be confirmed.More details about product were needed to perform a further analysis.The most probable root cause was that damage occurred during the use of the device since the breakage occurred 10 days after the start of use, not during initial device installation.No corrective actions were taken since the investigation did not reveal that the defect was caused during the manufacturing process.

• Brand Name: BIVONA AIRE-CUF NEO/PED TRACHEOSTOMY TUBES
• 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; akasaka, minato-ku, tokyo; minneapolis, MN 55442
• MDR Report Key: 13499174
• Report Number: 3012307300-2022-03035
• Device Sequence Number: 3867684
• Product Code: JOH
• UDI-Device Identifier: 15021312000306
• UDI-Public: 15021312000306
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K083641
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2023

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: Health Professional
• Device Expiration Date: 09/23/2025
• Device Model Number: 65SP040
• Device Catalogue Number: 65SP040
• Device Lot Number: 4056234
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2021
• Supplement Date Received by Manufacturer: 04/25/2023
• Initial Report FDA Received Date: 02/09/2022
• Supplement Report FDA Received Date: 05/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2020
• 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