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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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New Search show TPLC since Back to Search Results
Device pad, alcohol, device disinfectant
Product CodeLKB
Device Class Unclassified


Premarket Reviews
ManufacturerDecision
BECTON DICKINSON & CO.
  SUBSTANTIALLY EQUIVALENT 1
CR BARD
  SUBSTANTIALLY EQUIVALENT 1
PROFESSIONAL DISPOSABLES INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 6 6
2015 1 1
2016 7 7
2017 43 43
2018 21 21
2019 37 37
2020 39 39
2021 40 40
2022 9 9
2023 29 29
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Device Markings/Labelling Problem 45 45
Device Contamination with Chemical or Other Material 40 40
Defective Component 33 33
Fluid/Blood Leak 28 28
Break 14 14
Use of Device Problem 13 13
Accessory Incompatible 8 8
Missing Information 7 7
Adverse Event Without Identified Device or Use Problem 5 5
Leak/Splash 4 4
Material Integrity Problem 3 3
Contamination 3 3
Product Quality Problem 2 2
Illegible Information 2 2
Patient-Device Incompatibility 2 2
Occlusion Within Device 2 2
Component Missing 2 2
Device Dislodged or Dislocated 2 2
Appropriate Term/Code Not Available 2 2
Physical Resistance/Sticking 2 2
Detachment Of Device Component 2 2
Insufficient Information 2 2
Defective Device 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Entrapment of Device 2 2
Device Alarm System 1 1
Loose or Intermittent Connection 1 1
Moisture or Humidity Problem 1 1
Disconnection 1 1
Fungus in Device Environment 1 1
Packaging Problem 1 1
Detachment of Device or Device Component 1 1
Crack 1 1
Device-Device Incompatibility 1 1
Reflux within Device 1 1
Contamination of Device Ingredient or Reagent 1 1
Inaccurate Information 1 1
Material Separation 1 1
Material Fragmentation 1 1
Separation Failure 1 1
Failure To Unwrap 1 1
Obstruction of Flow 1 1
No Flow 1 1
Contamination /Decontamination Problem 1 1
Chemical Problem 1 1
Expiration Date Error 1 1
Device Operates Differently Than Expected 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 76 76
No Known Impact Or Consequence To Patient 71 71
No Consequences Or Impact To Patient 34 34
No Patient Involvement 14 14
No Information 10 10
Obstruction/Occlusion 6 6
Choking 3 3
Unspecified Infection 3 3
Rash 2 2
Apnea 2 2
Hypersensitivity/Allergic reaction 2 2
Underdose 2 2
Foreign Body In Patient 2 2
Air Embolism 1 1
Airway Obstruction 1 1
Lethargy 1 1
Chemical Exposure 1 1
Blood Loss 1 1
No Code Available 1 1
Insufficient Information 1 1
Hypoglycemia 1 1
Low Blood Pressure/ Hypotension 1 1
Hypoxia 1 1
Bacterial Infection 1 1
Death 1 1
Eye Injury 1 1
Hyperglycemia 1 1
Respiratory Distress 1 1
Swelling 1 1
Anaphylactoid 1 1
Complaint, Ill-Defined 1 1
Diabetic Ketoacidosis 1 1
Reinfusion 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Alere San Diego II Nov-16-2011
2 Catheter Connections, Inc. II Sep-05-2014
3 MEDLINE INDUSTRIES, LP - Northfield II Mar-29-2024
4 Madison Polymeric Engineering II May-12-2017
5 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
6 Vygon Corporation I Jun-11-2011
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