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Device
sterilant, medical devices
Regulation Description
Liquid chemical sterilants/high level disinfectants.
Product Code
MED
Regulation Number
880.6885
Device Class
2
Premarket Reviews
Manufacturer
Decision
STERIS CORPORATION
SUBSTANTIALLY EQUIVALENT
5
MDR Year
MDR Reports
MDR Events
2020
32
32
2021
31
31
2022
16
16
2023
9
9
2024
8
8
Device Problems
MDRs with this Device Problem
Events in those MDRs
Improper or Incorrect Procedure or Method
24
24
Use of Device Problem
14
14
Fluid/Blood Leak
14
14
Leak/Splash
10
10
Problem with Sterilization
9
9
Adverse Event Without Identified Device or Use Problem
7
7
Chemical Problem
5
5
Break
4
4
Insufficient Information
4
4
Device Handling Problem
3
3
Failure to Disinfect
3
3
Device Markings/Labelling Problem
1
1
Device Contamination with Chemical or Other Material
1
1
Deformation Due to Compressive Stress
1
1
Material Too Rigid or Stiff
1
1
Insufficient Flow or Under Infusion
1
1
Contamination
1
1
Incorrect, Inadequate or Imprecise Result or Readings
1
1
Fire
1
1
Explosion
1
1
Power Problem
1
1
Shipping Damage or Problem
1
1
Device Emits Odor
1
1
Defective Device
1
1
Unintended Movement
1
1
No Apparent Adverse Event
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
36
36
Burning Sensation
21
21
Skin Discoloration
16
16
Insufficient Information
7
7
Skin Irritation
5
5
Anaphylactic Shock
5
5
Burn(s)
5
5
Chemical Exposure
4
4
No Known Impact Or Consequence To Patient
3
3
Irritation
3
3
No Consequences Or Impact To Patient
3
3
Nasal Obstruction
3
3
Caustic/Chemical Burns
3
3
Skin Burning Sensation
3
3
Bronchospasm
2
2
Cough
2
2
Wheezing
2
2
Unspecified Eye / Vision Problem
2
2
Blurred Vision
2
2
Eye Burn
2
2
Dyspnea
2
2
Headache
2
2
Low Blood Pressure/ Hypotension
2
2
Skin Inflammation/ Irritation
2
2
Swelling/ Edema
2
2
Decreased Sensitivity
1
1
Superficial (First Degree) Burn
1
1
Syncope/Fainting
1
1
Unspecified Respiratory Problem
1
1
Eye Pain
1
1
Pain
1
1
Red Eye(s)
1
1
Excessive Tear Production
1
1
Sore Throat
1
1
Asthma
1
1
Corneal Abrasion
1
1
Erythema
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Mckesson Medical-Surgical Inc. Corporate Office
II
Aug-26-2022
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