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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device sterilant, medical devices
Product CodeMED
Regulation Number 880.6885
Device Class 2


Premarket Reviews
ManufacturerDecision
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 8
STERIS CORPORATIONS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 35 35
2020 32 32
2021 31 31
2022 16 16
2023 9 9
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Improper or Incorrect Procedure or Method 33 33
Use of Device Problem 19 19
Fluid/Blood Leak 18 18
Adverse Event Without Identified Device or Use Problem 14 14
Failure to Disinfect 11 11
Problem with Sterilization 9 9
Leak/Splash 8 8
Chemical Problem 5 5
Device Handling Problem 4 4
Break 4 4
Insufficient Information 3 3
Appropriate Term/Code Not Available 2 2
Defective Device 2 2
Patient-Device Incompatibility 2 2
Deformation Due to Compressive Stress 1 1
Insufficient Flow or Under Infusion 1 1
Inadequate or Insufficient Training 1 1
Material Fragmentation 1 1
Device Reprocessing Problem 1 1
Contamination 1 1
Fire 1 1
Device Emits Odor 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Material Too Rigid or Stiff 1 1
Shipping Damage or Problem 1 1
Failure to Clean Adequately 1 1
Device Markings/Labelling Problem 1 1
Difficult to Open or Close 1 1
Device Contamination with Chemical or Other Material 1 1
Power Problem 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 33 33
Burning Sensation 23 23
Skin Discoloration 16 16
No Known Impact Or Consequence To Patient 13 13
Chemical Exposure 9 9
Insufficient Information 7 7
Skin Irritation 6 6
Irritation 6 6
Anaphylactic Shock 5 5
Burn(s) 5 5
No Code Available 5 5
No Consequences Or Impact To Patient 5 5
Respiratory Tract Infection 4 4
Unspecified Infection 4 4
Nasal Obstruction 3 3
Skin Burning Sensation 3 3
Skin Inflammation/ Irritation 2 2
Swelling/ Edema 2 2
Sore Throat 2 2
Unspecified Eye / Vision Problem 2 2
Cough 2 2
Wheezing 2 2
Burn, Thermal 2 2
Caustic/Chemical Burns 2 2
Bronchospasm 2 2
Blurred Vision 2 2
Dyspnea 2 2
Headache 2 2
Low Blood Pressure/ Hypotension 2 2
Erythema 1 1
Corneal Abrasion 1 1
Asthma 1 1
Bruise/Contusion 1 1
Swelling 1 1
Itching Sensation 1 1
Nausea 1 1
Pain 1 1
Red Eye(s) 1 1
Decreased Sensitivity 1 1
Superficial (First Degree) Burn 1 1
Syncope/Fainting 1 1
Eye Burn 1 1
Dizziness 1 1
Excessive Tear Production 1 1
Discomfort 1 1
Injury 1 1
Unspecified Respiratory Problem 1 1
Eye Pain 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical II Jul-05-2019
2 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
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