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

Model Number	67HA70
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when required.
Event or Problem Description
It was reported, that the device was found without a hole for securing the locking pin.No patient harm or involvement reported.
Additional Manufacturer Narrative
Device evaluation: a review of the component dhr for the locking strap shows all inspections were completed and passed.This is a molded neck flange and the locking strap hole is punched into the neck flange after the printing operation.The complaint was confirmed as a manufacturing issue.The hole was not punched by the manufacturing operator and the work instruction was not followed per operation.Based on the low occurrence and severity of risk, no corrective actions are planned at this time.Icu medical regularly analyzes complaint data and trends and will take further actions accordingly.

• Brand Name: BIVONA TRACHEOSTOMY TUBE, ADULT
• 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
• Manufacturer Contact: jim vegel
• MDR Report Key: 17121104
• Report Number: 3012307300-2023-06194
• Device Sequence Number: 20495518
• Product Code: JOH
• UDI-Device Identifier: 15021312013801
• UDI-Public: 15021312013801
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2023

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: 67HA70
• Device Catalogue Number: 67HA70
• Device Lot Number: 4254440
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 06/09/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2023
• Supplement Date Received by Manufacturer: 10/12/2023
• Initial Report FDA Received Date: 06/13/2023
• Supplement Report FDA Received Date: 11/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2022
• 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
• Patient Sex: Unknown