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

Model Number	67PFS35
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the cuff was not inflating despite massaging.No patient injury was reported.
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 this device history record review.A product sample was received for evaluation.Visual and functional testing were performed.One used sample with was inspected without its original packaging, with the certificate of safe handling and the obturator.Visual inspection was performed at 12 inches under normal lighting to the received unit in order to detect any damage on the cuff.The sample was inflated with air using 5 milliliter (ml) syringe, after that the cuff was gently manipulated.The whole cuff was inflated without abnormalities.It was demonstrated that the cuff was symmetrical, and no leak was detected.The root cause of the reported issue could not be confirmed as the reported issue could not be replicated at the time of the device evaluation.No corrective actions required since the complaint was not confirmed.

• Brand Name: BIVONA CUSTOMIZED TRACHEOSTOMY TUBES
• 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: kalyala venkata nagamalleswara rao ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 16496348
• Report Number: 3012307300-2023-02094
• Device Sequence Number: 6316359
• Product Code: JOH
• UDI-Device Identifier: 10351688518613
• UDI-Public: 10351688518613
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 03/07/2023

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 Expiration Date: 12/01/2025
• Device Model Number: 67PFS35
• Device Catalogue Number: 67PFS35
• Device Lot Number: 4083926
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2023
• Initial Report FDA Received Date: 03/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2021
• 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