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

Model Number	67P045
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Premarket (510k) number is unknown.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A product sample was received for evaluation.Visual and functional testing were performed.Two (2) were in used conditions inside their opened original packaging and one (1) was in new condition.Visual inspection was performed at 12? under normal lighting to received unit, in order to detect any damage on the cuff, airline or pilot balloon.No damaged could be detected.Samples were filled with 5cc of air in order to see if there was any functional problem.When inflating the sample 1 and 2 with air, it was seen that pilot balloon inflate but all the air was stuck it, and when inflating the sample 3 with air, a part was not inflated uniformly.During the verification, 32 assemblies were reviewed to see the complete manufacturing process of the air way and balloon.Once the units were assembled and cured, they were inflated with air and visually inspected 100% to see that the cuff inflated uniformly.It was observed that the air cuff symmetry test was correctly performed.The root cause was unable to be undetermined.Actions were taken to mitigate the reported issue: quality alert was generated to show the operators the procedure of teflon application in the cuff to prevent sticking to the shaft.Production personnel was trained on quality alert by area trainer.Also, a visual aid was released to show the operators the procedure of teflon application in the cuff to prevent sticking to the shaft.
Event or Problem Description
It was reported that three cuffs were unable to inflate.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: 15597598
• Report Number: 3012307300-2022-23860
• Device Sequence Number: 2315478
• Product Code: JOH
• UDI-Device Identifier: 15021312006285
• UDI-Public: 15021312006285
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 10/13/2022

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
• Operator of Device: Health Professional
• Device Model Number: 67P045
• Device Catalogue Number: 67P045
• Device Lot Number: 3771658
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2022
• Initial Report FDA Received Date: 10/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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