MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA UNCUFFED NEONATAL FLEX TEND; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Model Number	60PFS40
Medical Device Problem Codes	Break (1069); Defective Component (2292)
Health Effect - Clinical Code	Decreased Respiratory Rate (2485)
Date of Event	04/19/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the trach tube flange snapped while in use with a patient.This resulted in the need for an emergent trach change, no patient injury from trach change.
Additional Manufacturer Narrative
A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.Three (3) samples were returned, and two of the samples had damaged flanges (sample 2 and 3).The failure reported could not be reproduced using tools from the assembly process.Root cause cannot be associated with the manufacturing process since the failure reported could not be reproduced using the tools from molding or assembly.Therefore, the damage (hole) occurred after the product left the facility.No corrective actions were taken since the investigation did not reveal that the defect was caused during the manufacturing process.
Additional Manufacturer Narrative
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 the device history record review.Three used samples were received without their original packaging, with their certificate of safe handling and their obturator.During the visual inspection, two samples were found with a damaged flange.The root cause cannot be associated with the manufacturing process since the failure reported could not be reproduced using the tools from molding / assembly process.The damage occurred after the product left the manufacturing facilities.No corrective actions were taken since the investigation did not reveal that the defect was caused during the manufacturing process.

• Brand Name: BIVONA UNCUFFED NEONATAL FLEX TEND
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• 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; minneapolis, MN 55442
• MDR Report Key: 14498554
• Report Number: 3012307300-2022-09622
• Device Sequence Number: 5151444
• Product Code: JOH
• UDI-Device Identifier: 15021312005868
• UDI-Public: 15021312005868
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K944178
• 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): 04/14/2023

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 Expiration Date: 02/08/2024
• Device Model Number: 60PFS40
• Device Catalogue Number: 60PFS40
• Device Lot Number: 3748845
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2022
• 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: 04/26/2022
• Supplement Date Received by Manufacturer: 09/01/2022; 09/01/2022
• Initial Report FDA Received Date: 05/25/2022
• Supplement Report FDA Received Date: 09/29/2022; 04/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/29/2019
• 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