MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA MID-RANGE AIRE-CUF ADULT TRACHEOSTOMY TUB; TRACHEOSTOMY TUBE AND TUBE CUFF

Model Number	75HA70
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It is reported that the customer has a tube that is 1cm shorter than the previous one and has caused patient discomfort.No patient injury.
Additional Manufacturer Narrative
No product was returned for investigation.Dhr review was done, no issues related to the original complaint were found.

• Brand Name: BIVONA MID-RANGE AIRE-CUF ADULT TRACHEOSTOMY TUB
• 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): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; jianguo n. road; minneapolis, MN 55442
• MDR Report Key: 14102946
• Report Number: 3012307300-2022-06302
• Device Sequence Number: 14654096
• Product Code: JOH
• UDI-Device Identifier: 15021312013849
• UDI-Public: 15021312013849
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K081440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/13/2022

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
• Device Expiration Date: 08/25/2025
• Device Model Number: 75HA70
• Device Catalogue Number: 75HA70
• Device Lot Number: 3998051
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2022
• Initial Report FDA Received Date: 04/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2020
• 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