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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
BD
  SUBSTANTIALLY EQUIVALENT 1
BECTON, DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 1
INOPRO INC
  SUBSTANTIALLY EQUIVALENT 1
IRRIMAX CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
NEXT SCIENCE, LLC
  SUBSTANTIALLY EQUIVALENT 1
ORTHOPHOR, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 243 243
2018 317 317
2019 328 353
2020 393 427
2021 398 450
2022 153 194

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 160 172
No Flow 111 111
Battery Problem 105 105
Fluid/Blood Leak 93 159
Expulsion 88 88
Difficult to Insert 79 79
Leak/Splash 68 68
Overheating of Device 66 66
Delivered as Unsterile Product 65 129
Failure to Prime 64 64
Device Contaminated During Manufacture or Shipping 61 61
Mechanical Problem 59 59
Break 58 58
Disconnection 57 57
Failure to Power Up 57 57
Biocompatibility 53 53
Improper Flow or Infusion 45 45
Connection Problem 44 44
Defective Device 39 39
Inability to Irrigate 38 38
Smoking 34 34
Corroded 34 34
Appropriate Term/Code Not Available 32 32
Electrical /Electronic Property Problem 30 30
Defective Component 30 30
Infusion or Flow Problem 28 28
Noise, Audible 27 27
Pressure Problem 24 24
Device Contamination with Chemical or Other Material 22 22
Fracture 21 30
Material Rupture 21 21
Loose or Intermittent Connection 19 19
Device Operates Differently Than Expected 19 19
Power Problem 19 19
Adverse Event Without Identified Device or Use Problem 16 16
Melted 15 15
Material Deformation 13 13
Electrical Power Problem 13 13
Component Missing 13 13
Manufacturing, Packaging or Shipping Problem 12 12
Positioning Problem 11 11
Inaccurate Flow Rate 11 11
Device Emits Odor 10 10
Vibration 10 10
Protective Measures Problem 10 10
Material Integrity Problem 10 10
No Pressure 10 10
Inaccurate Delivery 10 10
Activation, Positioning or Separation Problem 10 10
Suction Problem 8 8
Decrease in Pressure 8 8
Burst Container or Vessel 8 8
Excessive Heating 8 8
No Apparent Adverse Event 8 8
Insufficient Information 7 7
Material Split, Cut or Torn 7 7
Device Alarm System 7 7
Disassembly 7 7
Temperature Problem 7 7
Device Dislodged or Dislocated 6 6
Obstruction of Flow 6 6
Structural Problem 6 6
Loss of Power 6 6
Difficult to Remove 5 5
Material Separation 5 5
Crack 5 5
Material Frayed 5 5
Failure to Deliver 5 5
Material Twisted/Bent 5 5
Mechanical Jam 4 4
Output Problem 4 4
Failure to Cut 4 4
Insufficient Flow or Under Infusion 4 4
Contamination /Decontamination Problem 4 4
Malposition of Device 4 4
Fire 4 4
Detachment Of Device Component 4 4
Shipping Damage or Problem 4 4
Use of Device Problem 3 3
Device Inoperable 3 3
Circuit Failure 3 3
Premature Discharge of Battery 3 3
Thermal Decomposition of Device 3 3
No Display/Image 3 3
Gas Output Problem 3 3
Communication or Transmission Problem 3 3
Sparking 3 3
Device Markings/Labelling Problem 3 3
Device Damaged Prior to Use 3 3
Electrical Shorting 3 3
Activation Failure 3 3
Explosion 3 3
Intermittent Loss of Power 3 3
Patient Device Interaction Problem 2 2
Component Misassembled 2 2
Separation Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Device Displays Incorrect Message 2 2
Material Fragmentation 2 3
Labelling, Instructions for Use or Training Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 657 758
No Consequences Or Impact To Patient 600 644
No Known Impact Or Consequence To Patient 362 368
No Patient Involvement 214 244
Foreign Body In Patient 33 33
Insufficient Information 27 28
No Information 19 19
No Code Available 17 17
Injury 12 12
Device Embedded In Tissue or Plaque 5 5
Not Applicable 4 4
Unspecified Infection 3 3
Necrosis 3 3
Hypersensitivity/Allergic reaction 2 2
High Blood Pressure/ Hypertension 1 1
Fluid Discharge 1 1
Blister 1 1
Reaction to Medicinal Component of Device 1 1
Seizures 1 1
Skin Discoloration 1 1
Sprain 1 1
Tissue Damage 1 1
Transient Ischemic Attack 1 1
Burning Sensation 1 1
Arthralgia 1 1
Joint Swelling 1 1
Post Operative Wound Infection 1 1
Arrhythmia 1 1
Bruise/Contusion 1 1
Death 1 1
Non specific EKG/ECG Changes 1 1
Erythema 1 1
Eye Injury 1 1
Hematoma 1 1

Recalls
Manufacturer Recall Class Date Posted
1 IrriMAX Corporation II Oct-24-2019
2 Maquet Cardiovascular, LLC II Mar-07-2019
3 Mckesson Medical-Surgical Inc. Corporate Office III Sep-26-2022
4 Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company II Nov-20-2018
5 Stryker Instruments Div. of Stryker Corporation II Mar-28-2018
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