BIVONA CUFFLESS PEDIATRIC TRACH TUBE

Report

• Report Number: MW5159790
• Event Type: Other
• Date Received: September 19, 2024
• Report Date: September 16, 2024
• Manufacturer: SMITHS MEDICAL ASD, INC.
• Product Code: JOH
• Report Source: Voluntary report
• Reporter Location: ID, US
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: Yes

Narratives

Description of Event or Problem · 0

THE BIVONA PEDIATRIC TRACHEOSTOMY TUBE IFU STATES THAT FOR STERILIZATION OF THIS PRODUCT A 40-MINUTE GRAVITY CYCLE TIMEFRAME IS INDICATED. IN CONTRAST TO THIS, THE STERILIZATION PACKAGING AND THE CHEMICAL INTEGRATOR IFU'S REQUIRED TO PROCESS THE PRODUCT BOTH INDICATE A STERILIZATION PARAMETER THAT MAY NOT EXCEED 30 MINUTES. THE MANUFACTURER CONFIRMED THAT A 40-MINUTE STERILIZATION TIME WAS ACCURATE AND STATED THAT THEIR TESTING PARAMETERS WERE CONDUCTED ON COMMERCIAL STERILIZING EQUIPMENT WITH SPECIALIZED PACKAGING THAT COULD ATTAIN THE REQUIREMENTS INDICATED IN THE IFU. AS A PRODUCT FREQUENTLY USED IN HOSPITALS, THESE PARAMETERS ARE NOT COMPATIBLE WITH HOSPITAL-GRADE STERILIZERS, PACKAGING, AND STERILIZATION PRODUCTS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1449441	BIVONA CUFFLESS PEDIATRIC TRACH TUBE	TUBE TRACHEOSTOMY AND TUBE CUFF	JOH	SMITHS MEDICAL ASD, INC.

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown		BIVONA AIRE-CUF| BIVONA AIRE-CUF| CUFFLESS FLEXTEND| MID-RANGE NEONATAL/PEDIATRIC TRACH TUBE| TTS| UNCUFFED

Terms

Patient problem · 1

• No Clinical Signs, Symptoms or Conditions

Type of report · 1

• Initial submission