MAUDE Adverse Event Report: SALTER LABS SALTER LABS NASAL CANNULA (INTERMEDIATE INFANT); CANNULA, NASAL, OXYGEN

Model Number 1615-7

Device Problem Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/06/2019

Event Type  malfunction  

Event Description

One side of nasal cannula tubing found apart at left side of connection.The nasal cannula was found separated at the y and was removed from the patient.A new cannula was placed on the patient and the patient had no adverse reaction.

• Brand Name: SALTER LABS NASAL CANNULA (INTERMEDIATE INFANT)
• Type of Device: CANNULA, NASAL, OXYGEN
• Manufacturer (Section D): SALTER LABS; 2365 camino vida roble; carlsbad CA 92011
• MDR Report Key: 8949617
• MDR Text Key: 156141652
• Report Number: 8949617
• Device Sequence Number: 1
• Product Code: CAT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 1615-7
• Device Catalogue Number: 1615-7
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/21/2019
• Event Location: Hospital
• Date Report to Manufacturer: 08/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1