MAUDE Adverse Event Report: SALTER LABS SALTER; TUBING, OXYGEN, 3-CHANNEL 30'

Model Number 2030-30

Device Problem Material Twisted/Bent (2981)

Patient Problem Low Oxygen Saturation (2477)

Event Date 07/19/2021

Event Type  Injury  

Manufacturer Narrative

The tubing that was kinked, showed that the connector which connects the delivery tube was sealed off from the rest of the cannula tubing.This caused a desaturated which hospitalized the patient.Based on the reported information the criteria for reporting an adverse event has been met.

Event Description

Patient hospitalized following desaturated; the firefighters have noticed a kink in the tubing oxygen.

• Brand Name: SALTER
• Type of Device: TUBING, OXYGEN, 3-CHANNEL 30'
• Manufacturer (Section D): SALTER LABS; 30 spur drive; el paso TX 79906
• MDR Report Key: 12337840
• MDR Text Key: 267214252
• Report Number: 3000219639-2021-00019
• Device Sequence Number: 1
• Product Code: BYX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial
• Report Date: 07/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 2030-30
• Device Catalogue Number: 2030-30
• Device Lot Number: 200831
• Date Manufacturer Received: 07/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization