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

Model Number	60PFPS40
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the trach tube seems to be deteriorating.The customer feels like this could potentially be life threatening due to the possibility of the patient aspirating debris into her lungs.Photo attached.
Additional Manufacturer Narrative
Additional information: g5.This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No lot number was provided; therefore, device history record review could not be completed.No product sample was received; therefore, visual and functional testing could not be performed.One photo was attached.Based on pictures attached on investigation, condition reported in complaint were visible, however, this does not assure us that there is still a failure of the process, since mishandling by the user by not adjusting the tracheostomy device correctly could cause the condition.The image shows as if the tube had been bitten or damaged with some tool.Based on this the failure mode cannot be confirmed.A sample is needed to perform a further analysis.Based on image provided, root cause could not be determined, therefore no action can be taken.If the product is returned, the manufacturer will reopen this complaint for further investigation.

• Brand Name: BIVONA FLEXTEND PEDIATRIC NEONATAL TRACHEOSTROMY
• 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: latanya evans ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 12863619
• Report Number: 3012307300-2021-11761
• Device Sequence Number: 1377440
• Product Code: JOH
• UDI-Device Identifier: 15021312516838
• UDI-Public: 15021312516838
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K944178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2023

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 Model Number: 60PFPS40
• Device Catalogue Number: 60PFPS40
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2021
• Supplement Date Received by Manufacturer: 01/30/2023
• Initial Report FDA Received Date: 11/23/2021
• Supplement Report FDA Received Date: 02/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Unknown