MAUDE Adverse Event Report: SALTER LABS SALTER LABS; CANNULA, ADULT CONVENTIONAL, OXYGEN W/3-CHANNEL TUBE 7'

Model Number 1053-7-50

Device Problem Material Integrity Problem (2978)

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

Event Date 01/08/2024

Event Type  malfunction  

Event Description

The eyeglass tube is coming loose or does not fit at the joint between the tube and the nasal part. .

Manufacturer Narrative

The disconnection could prevent the patient from receiving oxygen and become hypoxic.

• Brand Name: SALTER LABS
• Type of Device: CANNULA, ADULT CONVENTIONAL, OXYGEN W/3-CHANNEL TUBE 7'
• Manufacturer (Section D): SALTER LABS; 30 spur drive; el paso TX 79906
• Manufacturer (Section G): SALTER LABS; 30 spur drive; el paso TX 79906
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 18946341
• MDR Text Key: 338359252
• Report Number: 3000219639-2024-00029
• Device Sequence Number: 1
• Product Code: CAT
• UDI-Device Identifier: 10607411101110
• UDI-Public: 10607411101110
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1053-7-50
• Device Catalogue Number: 1053-7-50
• Device Lot Number: 367714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: No
• 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): Other