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

Model Number	67PFPS60
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2020
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.The samples were received without their original packaging inside a ziploc bag, in used conditions and with their certificate of decontamination.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.Results: no damaged could be detected.Functional test: samples were filled with 5cc of air according to flextend tts tracheostomy tube assembly in order to see if there was any functional problem.Results: when we were inflating the units with air, the cuff only inflated one side.According to the ifu, manipulated the pilot balloon and the cuff inflated completely.After the whole cuff inflated, deflated and inflated 4 times, all the times the cuff inflated completely.Based on the analysis conducted in the sample provided, the complaint was not confirmed.No corrective actions were taken since the complaint was not confirmed.Operator of device: 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 tracheostomy was leaking.The patient found out prior the device 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: 15459416
• Report Number: 3012307300-2022-19884
• Device Sequence Number: 6005463
• Product Code: JOH
• UDI-Device Identifier: 10351688518583
• UDI-Public: 10351688518583
• 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
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/20/2022

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: 05/14/2025
• Device Model Number: 67PFPS60
• Device Catalogue Number: 67PFPS60
• Device Lot Number: 3981989
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2022
• Initial Report FDA Received Date: 09/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2020
• 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