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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
BECTON, DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 1
INOPRO INC
  SUBSTANTIALLY EQUIVALENT 1
IRRIMAX CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
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 94 112

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 155 163
No Flow 111 111
Battery Problem 94 94
Fluid Leak 93 157
Expulsion 88 88
Difficult to Insert 79 79
Leak/Splash 68 68
Overheating of Device 65 65
Failure to Prime 63 63
Device Contaminated During Manufacture or Shipping 61 61
Delivered as Unsterile Product 58 110
Mechanical Problem 57 57
Disconnection 57 57
Break 56 56
Biocompatibility 53 53
Failure to Power Up 51 51
Improper Flow or Infusion 45 45
Connection Problem 43 43
Defective Device 39 39
Corroded 34 34
Smoking 33 33
Appropriate Term/Code Not Available 32 32
Defective Component 30 30
Electrical /Electronic Property Problem 29 29
Inability to Irrigate 27 27
Infusion or Flow Problem 26 26
Noise, Audible 24 24
Device Contamination with Chemical or Other Material 21 21
Material Rupture 21 21
Pressure Problem 20 20
Device Operates Differently Than Expected 19 19
Loose or Intermittent Connection 19 19
Fracture 18 23
Power Problem 18 18
Adverse Event Without Identified Device or Use Problem 16 16
Melted 14 14
Electrical Power Problem 13 13
Material Deformation 13 13
Component Missing 13 13
Manufacturing, Packaging or Shipping Problem 11 11
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
Inaccurate Delivery 10 10
Activation, Positioning or SeparationProblem 10 10
No Pressure 9 9
No Apparent Adverse Event 8 8
Suction Problem 8 8
Decrease in Pressure 8 8
Burst Container or Vessel 8 8
Excessive Heating 8 8
Material Split, Cut or Torn 7 7
Device Alarm System 7 7
Disassembly 7 7
Insufficient Information 7 7
Temperature Problem 6 6
Device Dislodged or Dislocated 6 6
Obstruction of Flow 6 6
Structural Problem 6 6
Loss of Power 6 6
Material Separation 5 5
Material Frayed 5 5
Difficult to Remove 5 5
Failure to Deliver 5 5
Material Twisted/Bent 5 5
Mechanical Jam 4 4
Output Problem 4 4
Malposition of Device 4 4
Failure to Cut 4 4
Detachment Of Device Component 4 4
Shipping Damage or Problem 4 4
Insufficient Flow or Under Infusion 4 4
Device Damaged Prior to Use 3 3
Device Inoperable 3 3
Circuit Failure 3 3
Premature Discharge of Battery 3 3
Gas Output Problem 3 3
Fire 3 3
No Display/Image 3 3
Device Markings/Labelling Problem 3 3
Sparking 3 3
Activation Failure 3 3
Communication or Transmission Problem 3 3
Electrical Shorting 3 3
Explosion 3 3
Patient Device Interaction Problem 2 2
Component Misassembled 2 2
Separation Problem 2 2
Intermittent Loss of Power 2 2
Therapeutic or Diagnostic Output Failure 2 2
Device Displays Incorrect Message 2 2
Contamination /Decontamination Problem 2 2
Display or Visual Feedback Problem 2 2
Labelling, Instructions for Use or Training Problem 2 2
Defective Alarm 2 2
Thermal Decomposition of Device 2 2
Crack 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 600 644
No Clinical Signs, Symptoms or Conditions 599 677
No Known Impact Or Consequence To Patient 362 368
No Patient Involvement 214 244
Foreign Body In Patient 33 33
Insufficient Information 24 24
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
Seizures 1 1
Skin Discoloration 1 1
Sprain 1 1
Tissue Damage 1 1
Transient Ischemic Attack 1 1
Burning Sensation 1 1
Arrhythmia 1 1
Bruise/Contusion 1 1
Death 1 1
Non specific EKG/ECG Changes 1 1
Eye Injury 1 1
Hematoma 1 1
Hypersensitivity/Allergic reaction 1 1
High Blood Pressure/ Hypertension 1 1
Fluid Discharge 1 1
Arthralgia 1 1
Joint Swelling 1 1
Post Operative Wound Infection 1 1
Blister 1 1
Reaction to Medicinal Component of Device 1 1

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