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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
ARMIS BIOPHARMA, INC.
  SUBSTANTIALLY EQUIVALENT 1
BD
  SUBSTANTIALLY EQUIVALENT 1
BECTON, DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 1
ERBE ELEKTROMEDIZIN GMBH
  SUBSTANTIALLY EQUIVALENT 1
INNOVACYN, INC.
  SUBSTANTIALLY EQUIVALENT 1
INOPRO INC
  SUBSTANTIALLY EQUIVALENT 1
IRRIMAX CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
NEXT SCIENCE, LLC
  SUBSTANTIALLY EQUIVALENT 1
ORTHOPHOR, LLC
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW MEDICAL LIMITED
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 328 353
2020 393 427
2021 398 450
2022 171 208
2023 333 372
2024 167 202

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 176 234
Battery Problem 174 174
Delivered as Unsterile Product 173 251
No Flow 83 83
Fluid/Blood Leak 80 146
Difficult to Insert 70 70
Inability to Irrigate 65 65
Adverse Event Without Identified Device or Use Problem 64 64
Failure to Power Up 63 63
Failure to Prime 61 61
Disconnection 53 53
Manufacturing, Packaging or Shipping Problem 52 52
Break 47 47
Mechanical Problem 46 46
Improper Flow or Infusion 46 46
Overheating of Device 45 45
Connection Problem 44 44
Device Contaminated During Manufacture or Shipping 39 39
Leak/Splash 36 36
Crack 35 35
Expulsion 35 35
Pressure Problem 29 29
Noise, Audible 28 28
Corroded 28 28
Defective Component 28 28
Fracture 26 44
Electrical /Electronic Property Problem 24 24
Infusion or Flow Problem 23 23
Defective Device 23 23
Power Problem 22 22
Packaging Problem 20 20
Material Rupture 20 20
Smoking 19 19
Loose or Intermittent Connection 19 19
Appropriate Term/Code Not Available 19 19
Device Contamination with Chemical or Other Material 18 19
Suction Problem 14 14
Inaccurate Flow Rate 11 11
Vibration 10 10
Material Frayed 10 10
Electrical Power Problem 10 10
Activation, Positioning or Separation Problem 10 10
Protective Measures Problem 10 10
Activation Problem 10 10
Positioning Problem 9 9
No Pressure 9 9
Melted 9 9
Material Separation 9 9
Decrease in Pressure 8 8
Device Emits Odor 8 8
Contamination 8 8
Material Integrity Problem 8 8
No Apparent Adverse Event 8 8
Excessive Heating 8 8
Material Split, Cut or Torn 8 8
Material Twisted/Bent 7 7
Contamination /Decontamination Problem 7 7
Device Alarm System 7 7
Tear, Rip or Hole in Device Packaging 6 6
Obstruction of Flow 6 6
Inaccurate Delivery 5 5
Shipping Damage or Problem 5 5
Failure to Cut 5 5
Material Deformation 5 5
Intermittent Loss of Power 5 5
Explosion 4 4
Patient Device Interaction Problem 4 4
Insufficient Information 4 4
Device Dislodged or Dislocated 4 4
Use of Device Problem 4 4
Insufficient Flow or Under Infusion 4 4
Fitting Problem 4 4
Difficult to Remove 4 4
Loss of Power 3 3
Thermal Decomposition of Device 3 3
No Display/Image 3 3
Material Fragmentation 3 4
Communication or Transmission Problem 3 3
Activation Failure 3 3
Mechanical Jam 3 3
Therapeutic or Diagnostic Output Failure 2 2
Component Misassembled 2 2
Suction Failure 2 2
Separation Problem 2 2
Premature Separation 2 2
Device Markings/Labelling Problem 2 2
Sparking 2 2
Failure to Disconnect 2 2
Output Problem 2 2
Labelling, Instructions for Use or Training Problem 2 2
Display or Visual Feedback Problem 2 2
Unintended Power Up 2 2
Loss of or Failure to Bond 2 2
Burst Container or Vessel 2 2
Defective Alarm 2 2
Premature Discharge of Battery 2 2
Unsealed Device Packaging 2 2
Pumping Stopped 2 2
Unstable 2 2
Problem with Sterilization 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1098 1269
No Consequences Or Impact To Patient 303 347
No Known Impact Or Consequence To Patient 235 241
No Patient Involvement 121 151
Insufficient Information 47 51
Post Operative Wound Infection 25 25
Foreign Body In Patient 15 15
Impaired Healing 13 13
Hypersensitivity/Allergic reaction 11 11
Injury 10 10
Burning Sensation 9 9
No Information 6 6
No Code Available 5 5
Unspecified Infection 3 3
Necrosis 3 3
Burn(s) 2 2
Dyspnea 2 2
Swelling/ Edema 2 2
Device Embedded In Tissue or Plaque 2 2
Not Applicable 1 1
Embolism/Embolus 1 1
Blister 1 1
Reaction to Medicinal Component of Device 1 1
Erythema 1 1
Stroke/CVA 1 1
Purulent Discharge 1 1
Wound Dehiscence 1 1
Bruise/Contusion 1 1
Rash 1 1
Sprain 1 1
Tissue Damage 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 Medtronic Perfusion Systems II May-10-2024
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