MAUDE Adverse Event Report: FLEXICARE MEDICAL DONGGUAN LTD NIOFLO CANNULA INFANT; HIGH FLOW NASAL CANNULA

Catalog Number 032-13-253U

Device Problem Material Integrity Problem (2978)

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

Event Date 10/12/2020

Event Type  malfunction  

Event Description

The part which you connect the cannula to the circuit rotates, it kinks easily.Part where the tubing connects to the cannula separated.

• Brand Name: NIOFLO CANNULA INFANT
• Type of Device: HIGH FLOW NASAL CANNULA
• Manufacturer (Section D): FLEXICARE MEDICAL DONGGUAN LTD; no. b-15 xicheng ind zone 1; hengli town; dongguan city, guangdong 52346 0; CH 523460
• Manufacturer (Section G): FLEXICARE MEDICAL DONGGUAN; no. b-15 xicheng ind zone 1; hengli town; dongguan city, guangdong 52346 0; CH 523460
• Manufacturer Contact: darryl ridge ; cwm cynon business park; mountain ash, rct CF45 -4ER ; UK CF45 4ER
• MDR Report Key: 10790010
• MDR Text Key: 214758988
• Report Number: 3006061749-2020-00006
• Device Sequence Number: 1
• Product Code: CAT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 10/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 032-13-253U
• Device Lot Number: 200301948
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention