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

Model Number	60P045
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the pre-use check, a stain and a scratch were found in the product.No patient involvement.
Additional Manufacturer Narrative
Other text: additional information h6, h10.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.One sample was received within the original package with unsealed package.Visual inspection confirmed that there were stains on the piece and scratch on the tube tip.No other analysis was performed.The root cause was related to the manufacturing process.Customer complaint notification was performed to production personnel as awareness to failure mode reported.

• Brand Name: BIVONA UNCUFFED NEONATAL AND PEDIATRIC TRACHEOSTOM
• 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; 7-1-1 akasaka,; minneapolis, MN 55442
• MDR Report Key: 14063562
• Report Number: 3012307300-2022-06066
• Device Sequence Number: 20039039
• Product Code: BTO
• UDI-Device Identifier: 15021312005769
• UDI-Public: 15021312005769
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2023

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 Expiration Date: 05/20/2026
• Device Model Number: 60P045
• Device Catalogue Number: 60P045
• Device Lot Number: 4145691
• 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: 03/14/2022
• Supplement Date Received by Manufacturer: 12/22/2022
• Initial Report FDA Received Date: 04/08/2022
• Supplement Report FDA Received Date: 05/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2021
• 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