MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA NEO/PED TTS TRACHEOSTOMY TUBES; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	67SN035
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was unable to be evaluated as it was not returned.If the device is received in the future an evaluation will be performed.The reported event was unable to be confirmed or replicated.A cause of the reported event could not be determined at this time.
Event or Problem Description
It was reported that there was a ventilation leak noted in patient that could not resolve despite additional cuff inflation.The issue was resolved by changing out the trach.The ventilation was temporarily adjusted to compensate for the leak though the patient was clinically stable throughout.There was no patient injury reported.
Additional Manufacturer Narrative
One video was made available for the investigation.The video showed the cuff being inflated using a syringe filled with water.The cuff inflates asymmetrically, and the clinician manipulates by massaging and stretching the cuff; after this the cuff is symmetrical.The cuff is then deflated and once again inflated; the cuff inflates asymmetrically again.The complaint is confirmed.Without having the device in for investigation, root cause could not be established.An internal capa was opened on 18/jan/2022 to investigate the failure mode reported and is currently in investigation plan phase.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.E4 unknown.
Additional Manufacturer Narrative
Other, other text: this remediation mdr was generated under protocol b10010116, as a result of warning letter cms#617147.

• Brand Name: BIVONA NEO/PED TTS 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): NULL; 5700 west 23rd ave; gary IN 46406
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 13977917
• Report Number: 3012307300-2022-05711
• Device Sequence Number: 5554541
• Product Code: JOH
• UDI-Device Identifier: 15021312000252
• UDI-Public: 15021312000252
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K083641
• 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,Followup
• Report Date (Section B): 05/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/16/2025
• Device Model Number: 67SN035
• Device Catalogue Number: 67SN035
• Device Lot Number: 4016044
• Was Device Available for Evaluation?: No
• 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: 03/04/2022
• Supplement Date Received by Manufacturer: 09/21/2022; 04/10/2023
• Initial Report FDA Received Date: 04/01/2022
• Supplement Report FDA Received Date: 10/18/2022; 05/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown