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	08/23/2021
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 three days after starting to use the product, the customer noticed there was an alarm sounding from the cuff pressure gauge.They checked the product and the one-way valve was found damaged.There was no patient injury reported.
Additional Manufacturer Narrative
Other text: additional information: h6 and h10.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms#(b)(4).No problems or issues were identified during this device history record review.Visual and functional tests were performed.One (1) sample was received in used conditions, without its original packaging.The sample was visually inspected at a distance of 12" under normal lighting to receive unit.Based on the tests performed to replicate the failure mode, where it could not be reproduced using the tools from assembly process, the most probable root cause is that valve damage occurred during the use of the device since the breakage occurred 3 days after the start of use, not during initial device installation.This condition can be attributed to incorrect handling of the device.The root cause was undetermined.No corrective actions were taken since the investigation did not reveal that the defect was caused during the manufacturing process.
Additional Manufacturer Narrative
Other text: corrected data: b1, corrected data: corrected data: b1 product problem.

• 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: 13500078
• Report Number: 3012307300-2022-03048
• Device Sequence Number: 19812110
• 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,Followup
• Report Date (Section B): 06/14/2023

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: 09/15/2025
• Device Model Number: 65SP040
• Device Catalogue Number: 65SP040
• Device Lot Number: 4035684
• 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: 08/25/2021
• Supplement Date Received by Manufacturer: 09/16/2022; 06/13/2023
• Initial Report FDA Received Date: 02/09/2022
• Supplement Report FDA Received Date: 05/06/2023; 06/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2020
• 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