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

Model Number	60SP050
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that when the cap of the tracheostomy tube is pulled, the neck plate of the tracheostomy tube was completely torn off on one side.As a result, the tracheal cannula has come out of the stoma.
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 additional reportable information becomes available.
Additional Manufacturer Narrative
H10: a device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.No product sample was provided.A product photo was received for evaluation.Visual inspection found part broken from tracheostomy tube was detected; complaint was confirmed.No other analysis was performed.The root cause is the part damaged during use as stated in the complaint description.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# 617147.

• Brand Name: BIVONA TUBES NEO/PED
• 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; 5700 west 23rd ave; gary IN 46406
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; 3015 ca rotterdam; minneapolis, MN 55442
• MDR Report Key: 15954834
• Report Number: 3012307300-2022-27808
• Device Sequence Number: 15289038
• Product Code: JOH
• UDI-Device Identifier: 15021312000405
• UDI-Public: 15021312000405
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K912469
• 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,Followup
• Report Date (Section B): 03/27/2023

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: 07/20/2025
• Device Model Number: 60SP050
• Device Catalogue Number: 60SP050
• Device Lot Number: 4027993
• 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: 11/18/2022
• Supplement Date Received by Manufacturer: 01/19/2023
• Initial Report FDA Received Date: 12/09/2022
• Supplement Report FDA Received Date: 03/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2020
• 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: Other
• Patient Sex: Unknown