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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
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
2018 317 317
2019 328 353
2020 393 427
2021 398 450
2022 171 212
2023 290 329

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 175 217
Battery Problem 128 128
No Flow 111 111
Fluid/Blood Leak 97 163
Delivered as Unsterile Product 93 165
Difficult to Insert 79 79
Adverse Event Without Identified Device or Use Problem 67 67
Failure to Prime 62 62
Failure to Power Up 58 58
Mechanical Problem 58 58
Disconnection 57 57
Expulsion 56 56
Break 55 55
Leak/Splash 55 55
Inability to Irrigate 54 54
Improper Flow or Infusion 52 52
Manufacturing, Packaging or Shipping Problem 49 49
Overheating of Device 46 46
Connection Problem 44 44
Defective Device 40 40
Corroded 34 34
Crack 32 32
Appropriate Term/Code Not Available 32 32
Defective Component 30 30
Electrical /Electronic Property Problem 28 28
Noise, Audible 28 28
Pressure Problem 27 27
Biocompatibility 26 26
Infusion or Flow Problem 25 25
Fracture 25 34
Smoking 24 24
Device Contamination with Chemical or Other Material 23 24
Power Problem 21 21
Material Rupture 19 19
Loose or Intermittent Connection 19 19
Packaging Problem 17 17
Melted 13 13
Suction Problem 12 12
Material Integrity Problem 12 12
Component Missing 12 12
Electrical Power Problem 11 11
Inaccurate Flow Rate 11 11
Positioning Problem 10 10
No Pressure 10 10
Protective Measures Problem 10 10
Vibration 10 10
Activation, Positioning or Separation Problem 10 10
Material Deformation 9 9
Device Contaminated During Manufacture or Shipping 9 9
Material Frayed 9 9
Device Emits Odor 9 9
Excessive Heating 9 9
Decrease in Pressure 8 8
Material Separation 8 8
Contamination 8 8
No Apparent Adverse Event 8 8
Inaccurate Delivery 8 8
Obstruction of Flow 7 7
Contamination /Decontamination Problem 7 7
Device Alarm System 7 7
Material Split, Cut or Torn 7 7
Shipping Damage or Problem 6 6
Structural Problem 6 6
Insufficient Information 6 6
Temperature Problem 6 6
Material Twisted/Bent 6 6
Device Dislodged or Dislocated 5 5
Failure to Cut 5 5
Failure to Deliver 5 5
Difficult to Remove 5 5
Insufficient Flow or Under Infusion 4 4
Fitting Problem 4 4
Detachment Of Device Component 4 4
Malposition of Device 4 4
Output Problem 4 4
Mechanical Jam 4 4
Explosion 4 4
Intermittent Loss of Power 4 4
Activation Problem 4 4
Patient Device Interaction Problem 3 3
Activation Failure 3 3
Communication or Transmission Problem 3 3
Device Operates Differently Than Expected 3 3
Tear, Rip or Hole in Device Packaging 3 3
Premature Discharge of Battery 3 3
Thermal Decomposition of Device 3 3
Gas Output Problem 3 3
Material Fragmentation 3 4
No Display/Image 3 3
Loss of Power 3 3
Unsealed Device Packaging 3 3
Increase in Pressure 2 2
Pumping Stopped 2 2
Device Damaged Prior to Use 2 2
Display or Visual Feedback Problem 2 2
Labelling, Instructions for Use or Training Problem 2 2
Burst Container or Vessel 2 2
Loss of or Failure to Bond 2 2
Defective Alarm 2 2
Unintended Power Up 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 891 1031
No Consequences Or Impact To Patient 445 489
No Known Impact Or Consequence To Patient 306 312
No Patient Involvement 196 226
Insufficient Information 44 45
Foreign Body In Patient 31 31
Post Operative Wound Infection 25 25
Impaired Healing 13 13
Injury 12 12
No Code Available 11 11
Hypersensitivity/Allergic reaction 10 10
Burning Sensation 9 9
No Information 8 8
Not Applicable 3 3
Unspecified Infection 3 3
Necrosis 3 3
Device Embedded In Tissue or Plaque 2 2
Embolism/Embolus 1 1
Blister 1 1
Reaction to Medicinal Component of Device 1 1
Sprain 1 1
Tissue Damage 1 1
Wound Dehiscence 1 1
Arrhythmia 1 1
Bruise/Contusion 1 1
Burn(s) 1 1
Stroke/CVA 1 1
Purulent Discharge 1 1
Non specific EKG/ECG Changes 1 1
Erythema 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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