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

Model Number	67PFS45
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the cuffs of two trachs are not inflating symmetrically and only inflates on one side.The cuffs were massaged and inflation was attempted again with no resolution.No patient injury was reported.
Additional Manufacturer Narrative
H10: device evaluation: two (2) sample were received in used conditions.Functional test: air cuff symmetry test was performed to the units according to mp bivona tt-tj130 rev.102 ? "leak test" and av-10006853 rev.101 - leak testing and cuff symmetry visual aid.Cuff symmetry fixture was used (id: 13.3053-50 due: 10/2022).Results: when the sample was inflated with air, the cuff only inflated one side.According to the ifu (10018853-001 rev.100, instructions for use - pedi/neo tts ifu (pnt)) the pilot balloon was manipulated, and the cuff inflated.After the whole cuff inflated, it was deflated and inflated 4 times, all the times the cuff inflated completely.When measuring the cuffs, the percentage for the symmetry were: sample 1= 35%; sample 2= 40%.These results are over 33.3% that is the minimum acceptable.Based on the test, the units are within spec.The complaint is not confirmed.No root cause could be determinate since the samples successfully passed cuff symmetry test.

• Brand Name: BIVONA
• Common Device Name: TRACHEOSTOMY TUBE
• 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: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 13176331
• Report Number: 3012307300-2022-00218
• Device Sequence Number: 19988757
• Product Code: JOH
• UDI-Device Identifier: 10351688518637
• UDI-Public: 10351688518637
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/11/2025
• Device Model Number: 67PFS45
• Device Lot Number: 4051665
• 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: 12/16/2021
• Supplement Date Received by Manufacturer: 05/03/2022
• Initial Report FDA Received Date: 01/06/2022
• Supplement Report FDA Received Date: 06/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2020
• 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
• Patient Sex: Unknown