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

Model Number	67P050
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Two used samples were received to perform an investigation.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.Functional testing of the tracheostomy tube was performed by filling the cuffs with 5cc of air.The cuffs only inflated on one side.The cuffs were then manipulated and the whole cuff inflated.After the whole cuff inflated, the cuff was then deflated and inflated 4 times and all 4 times the cuffs inflated completely.The cuffs appeared asymmetrical when they were fully inflated so they were measured using the cuff symmetry fixture.Measurement was found to be within specification.The reported complaint was not confirmed.No root cause could be determined as the complaint could not be confirmed.A corrective and preventive action (capa) was opened to address this trend.Operator of device is unknown.No information has been provided to date.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 during pre-test, the tracheostomy tube cuff was in a blocked and not round state.No patient injury was reported.

• Brand Name: BIVONA PEDIATRIC TTS TRACHEOSTOMY TUBE
• 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: 15463051
• Report Number: 3012307300-2022-20063
• Device Sequence Number: 17856325
• Product Code: JOH
• UDI-Device Identifier: 15021312006292
• UDI-Public: 15021312006292
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K944178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/21/2022

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: 12/01/2024
• Device Model Number: 67P050
• Device Catalogue Number: 67P050
• Device Lot Number: 3901290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2022
• Initial Report FDA Received Date: 09/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2020
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown