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

Model Number	67P055
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/17/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by a nurse that the cuff on the patient's new tracheostomy tube was defective.This event occurred at the patient's home during pre-test of the device.No patient injury was reported.
Additional Manufacturer Narrative
Pictures and a used sample were received to perform an investigation.The pictures showed the tracheostomy cuff inflated with water.The cuff looked to be asymmetrical in one of the pictures.A visual inspection of the returned device was performed at 12 inches under normal lighting, in order to detect any damage on the cuff, airline or pilot balloon.No discrepancies were found.Functional testing was done by inflating the unit with air and the cuff inflated without problems; however, the cuff looked asymmetrical.A symmetry test was done on the trach cuff and found the unit to be within specification.A device history record (dhr) review was performed, and no issues were noted during manufacture.The reported problem was not confirmed.No root cause could be determined as the complaint could not be confirmed.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• 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: 15443069
• Report Number: 3012307300-2022-19553
• Device Sequence Number: 5569259
• Product Code: JOH
• UDI-Device Identifier: 15021312006308
• UDI-Public: 15021312006308
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K944178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/17/2022

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 Expiration Date: 10/15/2024
• Device Model Number: 67P055
• Device Catalogue Number: 67P055
• Device Lot Number: 3894896
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2020
• 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: 07/10/2022
• Initial Report FDA Received Date: 09/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2019
• 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