Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SALTER LABS SALTER LABS; ADULT DIVIDED CANNULA SOFT W/ 14' O2 LINE AND 14' CO2 LINE W/ MALE LUER-STYLE CO
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SALTER LABS SALTER LABS; ADULT DIVIDED CANNULA SOFT W/ 14' O2 LINE AND 14' CO2 LINE W/ MALE LUER-STYLE CO Back to Search Results
Model Number 49SOFT-TG-14-14-25
Device Problem Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/18/2024
Event Type  malfunction  
Event Description
It was brought to my attention that a few crna's have been finding o2 cannulas that are occluded again.One of them the whole nasal tubing that connects to the green tubing, one side of it was completely off.So far, i have had 3 complaints from today.I have one of the occluded tubing's that was used today and the start of the case it had to be changed.02 line occluding.
 
Manufacturer Narrative
This would cause the patient to desaturate.
 
Manufacturer Narrative
This would cause the patient to desaturate.The complaint of "o2 cannulas the whole nasal tubing that connects to the green tubing, one side of it was completely off" regarding part 49soft-tg-14-14-25 was not confirmed.The root cause was not determined.A risk assessment was performed, and the ultimate risk was determined to be medium which does require reporting to the capa review board.There have been 0 other complaints regarding the same part and a similar issue within the 24 months preceding the reporting of this issue.A resolution letter was sent to the customer.Complaints will continue to be monitored for possible trends.
 
Event Description
It was brought to my attention that a few crna's have been finding o2 cannulas that are occluded again.One of them the whole nasal tubing that connects to the green tubing, one side of it was completely off.So far, i have had 3 complaints from today.I have one of the occluded tubing's that was used today and the start of the case it had to be changed.02 line occluding.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SALTER LABS
Type of Device
ADULT DIVIDED CANNULA SOFT W/ 14' O2 LINE AND 14' CO2 LINE W/ MALE LUER-STYLE CO
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 Key18727805
MDR Text Key336642221
Report Number3000219639-2024-00018
Device Sequence Number1
Product Code CAT
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/16/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/16/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number49SOFT-TG-14-14-25
Device Catalogue Number49SOFT-TG-14-14-25
Device Lot Number456401
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/18/2024
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 Number1
Patient Outcome(s) Other;
-
-