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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device lavage, jet
Product CodeFQH
Regulation Number 880.5475
Device Class 2


Premarket Reviews
ManufacturerDecision
ALCAVIS HDC LLC
  SUBSTANTIALLY EQUIVALENT 1
ALCAVIS INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
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 4
NEXT SCIENCE, LLC
  SUBSTANTIALLY EQUIVALENT 2
ORTHOPHOR, LLC
  SUBSTANTIALLY EQUIVALENT 1
PATRIN PHARMA
  SUBSTANTIALLY EQUIVALENT 1
PREMIER BRANDS OF AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW MEDICAL LIMITED
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2014 194 194
2015 116 116
2016 150 150
2017 243 243
2018 317 317
2019 328 353
2020 393 427
2021 398 450
2022 171 208
2023 333 372
2024 75 98

Device Problems MDRs with this Device Problem Events in those MDRs
Battery Problem 192 192
Detachment of Device or Device Component 189 245
Delivered as Unsterile Product 152 227
Disassembly 130 130
Leak/Splash 119 119
Overheating of Device 116 116
No Flow 116 116
Fluid/Blood Leak 115 181
Break 101 101
Expulsion 97 97
Device Contaminated During Manufacture or Shipping 87 87
Difficult to Insert 79 79
Adverse Event Without Identified Device or Use Problem 76 76
Failure to Power Up 75 75
Biocompatibility 67 67
Failure to Prime 66 66
Inability to Irrigate 62 62
Mechanical Problem 62 62
Disconnection 58 58
Device Operates Differently Than Expected 53 53
Improper Flow or Infusion 53 53
Manufacturing, Packaging or Shipping Problem 52 52
Smoking 52 52
Connection Problem 49 49
Device Contamination with Chemical or Other Material 47 48
Corroded 46 46
Noise, Audible 43 43
Defective Device 42 42
Appropriate Term/Code Not Available 39 39
Burst Container or Vessel 35 35
Crack 34 34
Fracture 34 45
Electrical /Electronic Property Problem 34 34
Defective Component 31 31
Device Inoperable 30 30
Melted 29 29
Pressure Problem 29 29
Infusion or Flow Problem 28 28
Material Rupture 28 28
Packaging Problem 26 26
Power Problem 23 23
Loose or Intermittent Connection 20 20
Component Missing 16 16
Inaccurate Delivery 16 16
Detachment Of Device Component 15 15
Device Emits Odor 14 14
Suction Problem 14 14
Electrical Power Problem 13 13
Temperature Problem 13 13
Material Deformation 13 13
Material Integrity Problem 12 12
Positioning Problem 12 12
No Pressure 11 11
Inaccurate Flow Rate 11 11
Decrease in Pressure 11 11
Material Frayed 10 10
Activation, Positioning or Separation Problem 10 10
Vibration 10 10
Material Separation 10 10
Protective Measures Problem 10 10
Insufficient Information 10 10
No Apparent Adverse Event 9 9
Excessive Heating 9 9
Contamination 9 9
Loss of Power 9 9
Difficult to Remove 8 8
Contamination /Decontamination Problem 8 8
Material Split, Cut or Torn 8 8
Activation Problem 8 8
Material Twisted/Bent 7 7
Sparking 7 7
Tear, Rip or Hole in Device Packaging 7 7
Obstruction of Flow 7 7
Device Alarm System 7 7
Fire 7 7
Thermal Decomposition of Device 6 6
Cut In Material 6 6
Structural Problem 6 6
Use of Device Problem 6 6
Failure to Deliver 6 6
Shipping Damage or Problem 6 6
Improper or Incorrect Procedure or Method 6 6
Electrical Shorting 6 6
Device Dislodged or Dislocated 6 6
Insufficient Flow or Under Infusion 5 5
Failure to Cut 5 5
Explosion 5 5
Intermittent Loss of Power 4 4
Mechanical Jam 4 4
Patient Device Interaction Problem 4 4
Output Problem 4 4
Fitting Problem 4 4
Malposition of Device 4 4
Component Falling 4 4
Circuit Failure 4 4
Material Fragmentation 4 5
Gas Output Problem 3 3
No Display/Image 3 3
Premature Discharge of Battery 3 3
Unsealed Device Packaging 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1006 1164
No Consequences Or Impact To Patient 795 839
No Known Impact Or Consequence To Patient 531 537
No Patient Involvement 275 305
Insufficient Information 47 51
No Information 44 44
Foreign Body In Patient 35 35
Post Operative Wound Infection 25 25
No Code Available 23 23
Injury 14 14
Impaired Healing 13 13
Burning Sensation 10 10
Hypersensitivity/Allergic reaction 10 10
Tissue Damage 5 5
Device Embedded In Tissue or Plaque 5 5
Not Applicable 5 5
Unspecified Infection 4 4
Necrosis 3 3
Burn(s) 3 3
Cellulitis 2 2
Dyspnea 2 2
Hematoma 2 2
Erythema 2 2
Therapeutic Effects, Unexpected 2 2
Radiation Exposure, Unintended 2 2
Swelling/ Edema 2 2
Embolism/Embolus 1 1
Blister 1 1
Reaction to Medicinal Component of Device 1 1
Superficial (First Degree) Burn 1 1
Fluid Discharge 1 1
Transient Ischemic Attack 1 1
Pain 1 1
Seizures 1 1
Skin Discoloration 1 1
Sprain 1 1
Swelling 1 1
Arthralgia 1 1
Joint Swelling 1 1
Low Oxygen Saturation 1 1
Eye Burn 1 1
Caustic/Chemical Burns 1 1
Chemical Exposure 1 1
Eye Injury 1 1
Bone Fracture(s) 1 1
Hearing Loss 1 1
Hemorrhage/Bleeding 1 1
High Blood Pressure/ Hypertension 1 1
Low Blood Pressure/ Hypotension 1 1
Non specific EKG/ECG Changes 1 1
Embolism 1 1
Wound Dehiscence 1 1
Arrhythmia 1 1
Bruise/Contusion 1 1
Stroke/CVA 1 1
Death 1 1
Purulent Discharge 1 1

Recalls
Manufacturer Recall Class Date Posted
1 EXP Pharmaceutical Services Corp II Jul-24-2015
2 IrriMAX Corporation II Oct-24-2019
3 Maquet Cardiovascular, LLC II Mar-07-2019
4 Mckesson Medical-Surgical Inc. Corporate Office III Sep-26-2022
5 Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company II Nov-20-2018
6 Stryker Instruments Div. of Stryker Corporation II Mar-28-2018
7 Stryker Instruments Div. of Stryker Corporation II Jul-13-2015
8 Stryker Instruments Division of Stryker Corporation II Jan-25-2011
9 Zimmer Inc. II Jul-23-2009
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