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

Model Number	67PFS40
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No lot number was provided; therefore, device history record (dhr) review could not be completed.A product sample was received for evaluation.Visual and functional testing were performed.Visual inspection found the sample was received without its original packaging inside a ziploc bag, in used conditions and without its certificate of decontamination.Functional testing did not observe any leakage.The unit was inflated and visually inspected it for 10 seconds.Then the unit was submerged under water and no leakage was observed.The unit was also massaged, then squeezed it and we moved the airway line back and forth.We did not detected leaks during the test.Based on the analysis conducted in the sample provided, the complaint was not confirmed.The root cause of the issue could not be determined.This issue will be monitored for any increase in occurrence.If the occurrence of this issue increases significantly, additional investigative action will be taken.Date received by manufacturer is unknown.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
Event or Problem Description
It was reported that the patient received two trach tubes, both of which would not hold air.Occurred prior to patient use.No patient injury was reported.

• Brand Name: BIVONA
• 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): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15417530
• Report Number: 3012307300-2022-19099
• Device Sequence Number: 17773729
• Product Code: JOH
• UDI-Device Identifier: 10351688518620
• UDI-Public: 10351688518620
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/14/2022

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 Model Number: 67PFS40
• Device Catalogue Number: 67PFS40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2022
• Initial Report FDA Received Date: 09/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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