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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 235 241

Device Problems MDRs with this Device Problem Events in those MDRs
Delivered as Unsterile Product 293 369
Battery Problem 187 187
Detachment of Device or Device Component 178 255
Inability to Irrigate 127 127
Overheating of Device 94 94
Failure to Power Up 89 89
Fluid/Blood Leak 77 122
Adverse Event Without Identified Device or Use Problem 74 74
Crack 58 58
Failure to Prime 58 58
Explosion 58 58
Manufacturing, Packaging or Shipping Problem 53 53
Improper Flow or Infusion 49 49
Device Contaminated During Manufacture or Shipping 49 53
Difficult to Insert 48 48
Pressure Problem 46 46
Connection Problem 43 43
Break 39 39
No Flow 35 35
Noise, Audible 33 33
Expulsion 30 30
Activation Problem 28 28
Fracture 27 46
Appropriate Term/Code Not Available 26 26
Power Problem 25 25
Material Rupture 23 23
Leak/Splash 23 23
Corroded 22 22
Disconnection 22 22
Electrical /Electronic Property Problem 22 22
Infusion or Flow Problem 21 21
Packaging Problem 21 21
Defective Device 20 20
Loose or Intermittent Connection 19 19
Mechanical Problem 19 19
Smoking 17 17
Device Contamination with Chemical or Other Material 15 16
Suction Problem 13 13
Material Deformation 12 12
Activation, Positioning or Separation Problem 11 11
Melted 11 11
Defective Component 11 11
Protective Measures Problem 10 10
Vibration 10 10
Contamination 9 9
Material Frayed 9 9
Material Integrity Problem 9 9
Material Twisted/Bent 9 9
Material Separation 9 9
Decrease in Pressure 8 8

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1558 1754
No Consequences Or Impact To Patient 193 218
No Patient Involvement 78 104
No Known Impact Or Consequence To Patient 72 72
Insufficient Information 67 72
Post Operative Wound Infection 26 26
Impaired Healing 13 13
Hypersensitivity/Allergic reaction 12 12
Foreign Body In Patient 10 11
Burning Sensation 9 9
No Information 6 6
Rash 6 6
Injury 6 6
Burn(s) 3 3
Hematoma 3 3
Unspecified Infection 3 3
Laceration(s) 3 3
Necrosis 3 3
Aspiration/Inhalation 2 2
Cerebrospinal Fluid Leakage 2 2
Purulent Discharge 2 2
Dyspnea 2 2
Reaction to Medicinal Component of Device 2 2
Swelling/ Edema 2 2
No Code Available 2 2
Wound Dehiscence 1 1
Myocardial Contusion 1 1
Stroke/CVA 1 1
Erythema 1 1
Hemorrhage/Bleeding 1 1
Blister 1 1
Skin Inflammation/ Irritation 1 1
Embolism/Embolus 1 1
Itching Sensation 1 1
Renal Failure 1 1
Shock 1 1
Tissue Damage 1 1
Low Cardiac Output 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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