MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX OXYGEN/AEROSOL NASAL CANNULAS; MASK, OXYGEN

Catalog Number 001293

Device Problem Infusion or Flow Problem (2964)

Patient Problem Low Oxygen Saturation (2477)

Event Date 01/14/2021

Event Type  Injury  

Manufacturer Narrative

Device evaluation results: the portex oxygen/aerosol nasal cannula was returned for investigation.The investigator checked all the lines for any signs of occlusion using air as well as 5x-20x microscopy.All of the interior flow pathways throughout the entire device looked to be proper in appearance, and no obstructions, or occlusions were identified.The customer reported product problem was not confirmed.The problem source of the reported product problem was unknown.A root cause was not established.

Event Description

It was reported that the prongs that go into the patient's (not oxygen dependent) nose were only picking up carbon dioxide.Also, the second line was occluded.The incident caused the oxygen stats to drop in the patient requiring medical intervention rescue with an ambu-bag.No further patient complications were reported in relation to this event.

• Brand Name: PORTEX OXYGEN/AEROSOL NASAL CANNULAS
• Type of Device: MASK, OXYGEN
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• MDR Report Key: 11315214
• MDR Text Key: 231419018
• Report Number: 3012307300-2021-01172
• Device Sequence Number: 1
• Product Code: BYG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial
• Report Date: 02/11/2021

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: No Information
• Device Catalogue Number: 001293
• Device Lot Number: 2210416
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/15/2021
• Initial Date FDA Received: 02/11/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1