MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA TRACHEOSTOMY TUBE, NEONATAL/PEDIATRIC; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Model Number 67PFSS35

Device Problem Patient Device Interaction Problem (4001)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/24/2021

Event Type  malfunction  

Event Description

It was reported that a patient chewed through the cuff of a smiths medical trach tube.No adverse patient effects were reported.

Manufacturer Narrative

Other, other text: patient details were updated, dob.

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.Visual and functional testing were performed.Two (2) samples were received in used conditions, without its original packaging and with its certificate of safe handling.The sample was visually inspected at a distance of 12 inches under normal lighting to received unit.According with visual inspection, condition reported in complaint is visible, however, this does not assure us that there is still a failure of the process, according to the description of the complaint, the patient chewed through the cuff, it is clearly seen in the images marks or perforations caused by teeth causing leakage in the air valve.Based on this the failure mode cannot be confirmed.A review of the manufacturing process for was conducted by quality engineer in order to verify that there are no situations or practices that could create the event.No discrepancies were found.The root cause of the reported issue was found to be that the damaged occurred by the customer after the product left the facilities due to parts are 100% tested by leak and cuff symmetry test and the valve is needed to inflate the cuff.No corrective actions were taken since the investigation did not reveal that the defect was caused during the manufacturing process.

• Brand Name: BIVONA TRACHEOSTOMY TUBE, NEONATAL/PEDIATRIC
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• 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: 12764034
• MDR Text Key: 280465956
• Report Number: 3012307300-2021-10827
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 10351688518682
• UDI-Public: 10351688518682
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K923878
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: Lay User/Patient
• Device Model Number: 67PFSS35
• Device Catalogue Number: 67PFSS35
• Device Lot Number: 4148021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/12/2021
• Initial Date FDA Received: 11/07/2021
• Supplement Dates Manufacturer Received: 11/08/2021; 02/20/2023
• Supplement Dates FDA Received: 11/26/2021; 03/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 1 YR
• Patient Sex: Female