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

Model Number	60PFSS30
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a routine trach change was being done on (b)(6) 2021.Throughout the day, the family noticed the patient being more vocal than usual.When asleep, the patient started showing signs of respiratory distress.To troubleshoot, the family made sure the trach was in the neck properly and that they could pass a suction catheter through it.As a precaution, family did another trach change and the patient stabilized after that.While examining the old trach, a flap of clear thin flexible plastic was found in the inner wall of the cannula.It was assumed that when the patient took in a breath, the flap would go up and allow airflow but when exhaling, the flap would go down and close off or limit airflow.
Additional Manufacturer Narrative
Corrected data: date of event updated, issue occurred while in use with a patient, and was resolved by swapping out the device.Patient information updated.
Additional Manufacturer Narrative
One unit was returned for investigation.Upon physical inspection, it was found that the complained issue could not be duplicated and the device passed all functional tests.Root cause could not be determined since the sample did not present any residue, plastic, or membrane on visual inspection.Dhr review was done, no issues related to the original complaint were found.

• Brand Name: BIVONA TUBES NEO/PED FLEXTEND PLUS
• Common Device Name: TRACHEOSTOMY TUBE 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: 12657996
• Report Number: 3012307300-2021-10087
• Device Sequence Number: 16445952
• Product Code: JOH
• UDI-Device Identifier: 15021312516760
• UDI-Public: 15021312516760
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/09/2022

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?: No
• Device Model Number: 60PFSS30
• Device Catalogue Number: 60PFSS30
• Device Lot Number: 41303977
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2021
• 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: 09/15/2021
• Supplement Date Received by Manufacturer: 11/15/2021; 02/08/2022
• Initial Report FDA Received Date: 10/19/2021
• Supplement Report FDA Received Date: 12/14/2021; 03/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Age: 2 YR
• Patient Sex: Male