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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device accessories, cleaning brushes, for endoscope
Product CodeMNL
Regulation Number 876.1500
Device Class 1

MDR Year MDR Reports MDR Events
2019 47 47
2020 28 28
2021 68 68
2022 60 60
2023 65 65
2024 14 14

Device Problems MDRs with this Device Problem Events in those MDRs
Break 164 164
Material Separation 16 16
Detachment of Device or Device Component 14 14
Entrapment of Device 13 13
Material Integrity Problem 10 10
Failure to Clean Adequately 9 9
Device Reprocessing Problem 9 9
Defective Device 9 9
Device Contaminated During Manufacture or Shipping 9 9
Adverse Event Without Identified Device or Use Problem 8 8
Failure to Disconnect 8 8
Use of Device Problem 7 7
Material Frayed 6 6
Inaccurate Information 5 5
Device Contamination with Chemical or Other Material 4 4
Fracture 3 3
Contamination 3 3
Problem with Sterilization 3 3
Mechanical Problem 3 3
Partial Blockage 3 3
Residue After Decontamination 3 3
Suction Problem 2 2
Device Damaged by Another Device 2 2
Difficult to Advance 2 2
Device Dislodged or Dislocated 2 2
Contamination /Decontamination Problem 2 2
Difficult to Remove 2 2
Material Fragmentation 2 2
Mechanical Jam 2 2
Naturally Worn 1 1
Difficult to Insert 1 1
Corroded 1 1
Degraded 1 1
Device Emits Odor 1 1
Improper or Incorrect Procedure or Method 1 1
Contamination of Device Ingredient or Reagent 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Insufficient Information 1 1
Device Handling Problem 1 1
Material Too Soft/Flexible 1 1
Physical Resistance/Sticking 1 1
Suction Failure 1 1
Defective Component 1 1
Fungus in Device Environment 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 200 200
No Patient Involvement 35 35
No Consequences Or Impact To Patient 20 20
No Known Impact Or Consequence To Patient 17 17
Insufficient Information 5 5
Foreign Body In Patient 3 3
Chemical Exposure 2 2
Hypersensitivity/Allergic reaction 2 2

Recalls
Manufacturer Recall Class Date Posted
1 MEDLINE INDUSTRIES, LP - Northfield II Jun-02-2022
2 Madison Polymeric Engineering II Jul-02-2019
3 Madison Polymeric Engineering II Feb-28-2019
4 Mckesson Medical-Surgical Inc. Corporate Office II Mar-19-2024
5 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
6 Medline Industries Inc II Aug-05-2020
7 Medline Industries Inc II Aug-06-2019
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