MAUDE Adverse Event Report: FLEXICARE MEDICAL LTD ADULT NASAL CANNULA WITH 2.1M OXYGEN TUBING

Catalog Number 032-10-022

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/05/2021

Event Type  malfunction  

Manufacturer Narrative

Event was submitted to the (b)(6), the assigned reference was (b)(4).Date of initial submission was 28 july 2021, final submission 01 september 2021.The device was returned to the manufacturer, where subsequent testing and product evaluation was carried out.The testing revealed no identified defects with the device, further communication with the end user has revealed that the cannula has potentially been incorrectly fitted, where the shoulder has not been secured under the patients nose to keep the device in position.Oxygen saturation levels are constantly monitored, therefore any decrease in supplementary oxygen would be easily noticable to the healthcare provider.There were no reported adverse health effects on the patient, the issue was identified before the alarms notified of any drop on saturation levels.

Event Description

Nasal catheters rotate away from the face, so pt does not get oxygen.

• Brand Name: ADULT NASAL CANNULA WITH 2.1M OXYGEN TUBING
• Type of Device: NASAL CANNULA
• Manufacturer (Section D): FLEXICARE MEDICAL LTD; cynon valley business park; mountain ash, CF45 4ER; UK CF45 4ER
• Manufacturer (Section G): FLEXICARE MEDICAL; flexicare medical; cynon valley business park; mountain ash, rct CF45 4ER; UK CF45 4ER
• Manufacturer Contact: julie davies ; cynon valley business park; mountain ash, rct CF45 -4ER ; UK CF45 4ER
• MDR Report Key: 15650355
• MDR Text Key: 307069230
• Report Number: 3006061749-2022-00015
• Device Sequence Number: 1
• Product Code: CAT
• Combination Product (y/n): N
• Reporter Country Code: DA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 032-10-022
• Device Lot Number: 200303985
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1