MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX BIVONA TRACH; TUBE, LARYNGECTOMY

Lot Number 4260060

Device Problems Material Puncture/Hole (1504); Gas/Air Leak (2946); Improper Flow or Infusion (2954)

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

Event Date 10/26/2022

Event Type  malfunction  

Event Description

During the procedure, (tracheostomy) a bivona pediatric tracheostomy tube flextend standard tts cuff tube 3.5mmid x 40mm lg the cuff was tested on the back table.It was then given to dr for placement in the trachea.When the anesthesia circuit was connected by dr, the patient was not being ventilated correctly.The trach was removed and replaced immediately with another tracheostomy tube, which worked.The 3.5mm x 40mmlg tracheostomy tube was removed from the table and it was noted by anesthesia that there is a small hole in the tubing that connects directly to the anesthesia circuit.Defective trach.Fda safety report id #(b)(4).

• Brand Name: PORTEX BIVONA TRACH
• Type of Device: TUBE, LARYNGECTOMY
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 15732593
• MDR Text Key: 303237033
• Report Number: MW5113069
• Device Sequence Number: 1
• Product Code: KAC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 4260060
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 7 MO
• Patient Sex: Female
• Patient Weight: 8 KG
• Patient Ethnicity: Hispanic
• Patient Race: White