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

Model Number	FT21GN35NGE965N
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the custom trach had a hole in the cuff right out the package.No patient involvement.
Additional Manufacturer Narrative
No product will be returned for investigation.
Additional Manufacturer Narrative
This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No problems or issues were identified during the device history record review.A product sample was received for evaluation.Visual and functional testing were performed.The technician confirmed that the device was manufactured by the company.The returned sample was subject to routine leak testing per procedure and was noted to contain a small hole in the pilot balloon.The cuff was unable to be inflated in any capacity, and it was immediately apparent that the tube contained a leakage issue.It's highly probable that this issue would have been detected by the in-process leak testing if it was present prior to the product being packaged, especially given the fact that the cuff was clearly unable to be inflated.The root cause of the reported issue could not be confirmed whether the product issue was caused during the manufacturing process or after it had left the control of the manufacture.This issue and the results of this investigation were communicated to the relevant manufacturing personnel to raise awareness of this issue.Causal factor could not be defined with confidence.Complaint information will continue to be monitored.Product was accepted based on meeting specification requirements.If any nonconformance's are found in process, the product was isolated, non-conformed and immediate action is taken to perform corrections.Inspections and tests are conducted by trained operators through 100% screening inspection before shipment.The manufacture regularly analyzes this feedback for potential trends, which may lead to additional corrections or corrective actions.

• Brand Name: BIVONA CUSTOMIZED TRACHEOSTOMY TUBES
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; suite 100; minneapolis, MN 55442
• MDR Report Key: 13314704
• Report Number: 3012307300-2022-01340
• Device Sequence Number: 16509688
• Product Code: JOH
• UDI-Device Identifier: 15019517274011
• UDI-Public: 15019517274011
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2023

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: FT21GN35NGE965N
• Device Catalogue Number: FT21GN35NGE965N
• Device Lot Number: ST009316
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 01/04/2022
• Supplement Date Received by Manufacturer: 02/09/2023
• Initial Report FDA Received Date: 01/21/2022
• Supplement Report FDA Received Date: 03/16/2023
• 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