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

Model Number	60SP040
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that 7 days after using the device, the customer found a crack in the base part of the side flange.It was emergently changed.No patient injury.No additional information is available for this complaint.
Additional Manufacturer Narrative
One photo was returned for investigation.Upon inspection, it was found that the complained issue could not be duplicated.Based on the image provided no root cause could be determined, therefore no action can be taken.If the product is returned, smiths medical will reopen this complaint for further investigation.

• Brand Name: BIVONA TUBES NEO/PED
• Common Device Name: TRACHEOSTOMY TUBE 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: 12677594
• Report Number: 3012307300-2021-10149
• Device Sequence Number: 4160932
• Product Code: JOH
• UDI-Device Identifier: 15021312000382
• UDI-Public: 15021312000382
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 60SP040
• Device Catalogue Number: 60SP040
• Device Lot Number: 4056234
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2021
• Supplement Date Received by Manufacturer: 12/16/2021; 06/14/2023
• Initial Report FDA Received Date: 10/21/2021
• Supplement Report FDA Received Date: 01/07/2022; 06/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2020
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown