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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device lavage, jet
Regulation Description Jet lavage.
Product CodeFQH
Regulation Number 880.5475
Device Class 2


Premarket Reviews
ManufacturerDecision
ARMIS BIOPHARMA, INC.
  SUBSTANTIALLY EQUIVALENT 1
BD
  SUBSTANTIALLY EQUIVALENT 1
BECTON, DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 1
ERBE ELEKTROMEDIZIN GMBH
  SUBSTANTIALLY EQUIVALENT 1
INOPRO INC
  SUBSTANTIALLY EQUIVALENT 1
IRRIMAX CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
NEXT SCIENCE, LLC
  SUBSTANTIALLY EQUIVALENT 1
ORTHOPHOR, LLC
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW MEDICAL LIMITED
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 393 427
2021 398 450
2022 171 208
2023 333 372
2024 425 480
2025 50 54

Device Problems MDRs with this Device Problem Events in those MDRs
Delivered as Unsterile Product 244 320
Battery Problem 187 187
Detachment of Device or Device Component 176 253
Inability to Irrigate 107 107
Failure to Power Up 81 81
Fluid/Blood Leak 77 122
Overheating of Device 71 71
Adverse Event Without Identified Device or Use Problem 70 70
Failure to Prime 58 58
Manufacturing, Packaging or Shipping Problem 52 52
Crack 51 51
Difficult to Insert 48 48
Improper Flow or Infusion 47 47
Device Contaminated During Manufacture or Shipping 43 45
Connection Problem 43 43
Explosion 40 40
Pressure Problem 39 39
Break 38 38
No Flow 35 35
Noise, Audible 30 30
Expulsion 29 29
Fracture 26 45
Appropriate Term/Code Not Available 23 23
Power Problem 22 22
Electrical /Electronic Property Problem 22 22
Material Rupture 22 22
Disconnection 22 22
Infusion or Flow Problem 21 21
Defective Device 20 20
Packaging Problem 20 20
Leak/Splash 19 19
Loose or Intermittent Connection 19 19
Corroded 19 19
Activation Problem 18 18
Smoking 17 17
Device Contamination with Chemical or Other Material 15 16
Suction Problem 12 12
Defective Component 11 11
Activation, Positioning or Separation Problem 11 11
Mechanical Problem 11 11
Protective Measures Problem 10 10
Melted 10 10
Vibration 10 10
Material Frayed 9 9
Material Twisted/Bent 9 9
Contamination 9 9
Material Separation 9 9
Material Split, Cut or Torn 8 8
Decrease in Pressure 8 8
Contamination /Decontamination Problem 8 8

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1391 1585
No Consequences Or Impact To Patient 193 218
No Patient Involvement 78 104
No Known Impact Or Consequence To Patient 72 72
Insufficient Information 55 60
Post Operative Wound Infection 26 26
Impaired Healing 13 13
Hypersensitivity/Allergic reaction 11 11
Foreign Body In Patient 10 11
Burning Sensation 9 9
Rash 6 6
No Information 6 6
Injury 6 6
Laceration(s) 3 3
Necrosis 3 3
Unspecified Infection 3 3
No Code Available 2 2
Burn(s) 2 2
Dyspnea 2 2
Swelling/ Edema 2 2
Sepsis 1 1
Tissue Damage 1 1
Embolism/Embolus 1 1
Wound Dehiscence 1 1
Aspiration/Inhalation 1 1
Stroke/CVA 1 1
Purulent Discharge 1 1
Erythema 1 1
Blister 1 1
Reaction to Medicinal Component of Device 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Mckesson Medical-Surgical Inc. Corporate Office III Sep-26-2022
2 Medtronic Perfusion Systems II May-10-2024
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