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

Model Number	750160
Medical Device Problem Code	Short Fill (1575)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Sample was received with its original packaging.Cuff symmetry test was performed to the unit.When the cuff was inflated with 15cc of air, the cuff inflated completely around the tube, however, the cuff sees asymmetrical.Then when the cuff was measured and the percentage for the symmetry was 35.48 percent.This result is over 33.3 percent that is the minimum acceptable for air cuff.Based on the test, the unit is within spec.The complaint is not confirmed.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.D5 operator of device is unknown this remediation mdr was generated under protocol b10009406, as a result of warning letter cms# 617147.
Event or Problem Description
It was reported that during a pre-use test, the customer noticed the cuff did not inflate normally.No patient injury was reported.

• Brand Name: BIVONA TRACHEOSTOMY TUBE, NEONATAL/PEDIATRIC
• 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): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; 3-10-15, hakata station east,; minneapolis, MN 55442
• MDR Report Key: 15410577
• Report Number: 3012307300-2022-18925
• Device Sequence Number: 6744710
• Product Code: JOH
• UDI-Device Identifier: 15021312006407
• UDI-Public: 15021312006407
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K914088
• 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
• Report Date (Section B): 09/13/2022

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: 11/11/2024
• Device Model Number: 750160
• Device Catalogue Number: 750160
• Device Lot Number: 3904496
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2022
• Initial Report FDA Received Date: 09/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2019
• 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