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

Model Number	670185
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device history record (dhr) review was conducted which indicated all inspection were completed and no issues were noted during manufacture.Samples were received without its original packaging and in used conditions.Visual inspection: visual inspection was performed at 12" under normal lighting to received units, in order to detect any damage on the cuff or airline.Results: no damage could be detected.Sample was inflated with 20cc of air and tested using a calibrated rule, symmetry and leak test method.Results: the cuff measured 15mm from the center of the shaft to the outside of the cuff and 21mm from the center of the shaft to the opposite side of the cuff.The cuff symmetry did not exceed the 60:40 ratio for tts cuff.The complaint is not confirmed.There is no root cause since the complaint was not confirmed.No corrective actions are required since the complaint was not confirmed.D5 uknown 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 customer has the tracheostomy taken out after three weeks of use, just before being reinserted, and the balloon was 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: 15418135
• Report Number: 3012307300-2022-19129
• Device Sequence Number: 6507206
• Product Code: JOH
• UDI-Device Identifier: 15021312006087
• UDI-Public: 15021312006087
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K083641
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Administrator/Supervisor
• 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
• Device Expiration Date: 09/28/2023
• Device Model Number: 670185
• Device Catalogue Number: 670185
• Device Lot Number: 3693990
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2022
• Initial Report FDA Received Date: 09/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/04/2018
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown