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

Model Number	65SP040
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer facility phone number: (b)(6).
Event or Problem Description
Information was received indicating that a smiths medical trach's flange was torn from the base.A trach change was performed by medical professionals to resolve the issue.Before and after the replacement, there was no particular change in respiratory status of the patient.There was no patient injury.There were no reported adverse events.
Additional Manufacturer Narrative
This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).A sample was received for evaluation.The sample was received in used condition, without its original packaging and with its certificate of safe handling.Visual inspection was performed under normal conditions of illumination and it was observed that one flange was broken.The failure is confirmed.The broken components were inspected using a digital microscope with a scale of 30x (magnification), to observe better the shape of the rupture in both components.Component one, it was observed that the cut was clean; no flash is observed in the periphery.In component two, the shape is clean; no flash was observed in the periphery.A retrospective review for the complaints related to this product family was completed and a total of two complaints had been received for this particular failure (broken flange).Both complaints were received from different part number and customer.This retrospective review concludes that there is no trend associated to this failure of broken flange.Based on the test performed, it is concluded that failure reported could not be reproduced during the molding process since the cut created is not in the same position as sample received, the reproduced cut is deeper than cut from sample received.Based on instruction for use, 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.Most probable root cause is that damaged occurred outside of manufacturing facilities.Although the defect could not be reproduced during molding process, production personnel was notified.

• 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): NULL; 5700 west 23rd ave; gary IN 46406
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; 3-21-2 motohama-cho, naka-ku,; minneapolis, MN 55442
• MDR Report Key: 11886438
• Report Number: 3012307300-2021-05096
• Device Sequence Number: 3710655
• Product Code: JOH
• UDI-Device Identifier: 15021312000306
• UDI-Public: 15021312000306
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K944178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2023

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 Model Number: 65SP040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2021
• Supplement Date Received by Manufacturer: 09/16/2022
• Initial Report FDA Received Date: 05/26/2021
• Supplement Report FDA Received Date: 04/28/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Race: Asian