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

Model Number	670175
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when opening and pre-testing cuff patency, the clinician found that the cuff leaked.No patient injury was reported.
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 function testing was performed.The evaluation received one 7.5mm id device was returned for cuff leaking.The product cuff was leak tested with air per procedure.The cuff was unable to fully inflate and immediately deflated as air escaped from a small hole or scratch in the tight to shaft (tts) cuff.Upon visual inspection of the cuff, it was noted that there are tiny scratches next to the small hole on the cuff and multiple other areas nearby the leaking hole that show signs of abrasions with tiny scratches not visibly leaking yet, perhaps caused by the device encountering contact with something sharp externally or potentially from hard cartilage internal to the patient.The root cause was unable to be undetermined.No actions were taken to mitigate the reported issue: no anomalies were found during review of dhr.The product is 100% inspected and leak tested during manufacturing, prior to shipping to the customer.

• Brand Name: BIVONA TRACHEOSTOMY TUBE, ADULT
• 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: 15598836
• Report Number: 3012307300-2022-23868
• Device Sequence Number: 2278433
• Product Code: JOH
• UDI-Device Identifier: 15021312006063
• UDI-Public: 15021312006063
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• 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: 670175
• Device Catalogue Number: 670175
• Device Lot Number: 3488076
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2019
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2022
• 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