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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device pump, infusion, elastomeric
Product CodeMEB
Regulation Number 880.5725
Device Class 2


Premarket Reviews
ManufacturerDecision
HALYARD HEALTH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 1653 1653
2018 1473 1564
2019 974 4421
2020 2731 3223
2021 1802 1802
2022 1058 1058

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 2484 5200
Filling Problem 2325 2837
Material Rupture 1352 1673
No Flow 1118 1393
Excess Flow or Over-Infusion 593 593
Infusion or Flow Problem 423 423
Break 238 260
Device Contamination with Chemical or Other Material 205 354
Leak/Splash 190 190
Failure to Infuse 188 188
Adverse Event Without Identified Device or Use Problem 151 151
Disconnection 146 146
Inaccurate Flow Rate 68 68
Component Missing 63 66
Crack 58 62
Contamination /Decontamination Problem 43 43
Improper Flow or Infusion 38 38
Loose or Intermittent Connection 33 34
Insufficient Flow or Under Infusion 32 32
Failure to Deliver 28 28
Detachment Of Device Component 27 27
Failure to Prime 22 22
Detachment of Device or Device Component 22 23
Device Operates Differently Than Expected 17 17
Material Split, Cut or Torn 16 17
Backflow 15 15
Material Deformation 14 15
Improper or Incorrect Procedure or Method 12 12
Reflux within Device 11 11
Physical Resistance/Sticking 10 10
Material Twisted/Bent 9 9
Device Contaminated During Manufacture or Shipping 7 7
Defective Device 7 7
Burst Container or Vessel 7 7
Misconnection 7 7
Defective Component 6 6
Material Puncture/Hole 6 9
Material Separation 6 6
Material Integrity Problem 6 6
Appropriate Term/Code Not Available 5 5
Inaccurate Delivery 5 5
Fracture 5 5
Material Fragmentation 4 4
Obstruction of Flow 4 4
Use of Device Problem 4 4
Split 4 4
Pumping Problem 4 4
Scratched Material 4 4
Device Dislodged or Dislocated 4 4
Device Operational Issue 3 3
Insufficient Information 3 3
Patient-Device Incompatibility 3 3
Mechanical Problem 3 3
Particulates 3 3
Partial Blockage 3 3
Deflation Problem 3 3
Degraded 3 3
Material Discolored 2 2
Hole In Material 2 2
Material Perforation 2 2
Device Damaged Prior to Use 2 2
Volume Accuracy Problem 2 2
Difficult to Remove 2 2
Retraction Problem 2 2
Product Quality Problem 2 2
Mechanical Jam 2 2
Noise, Audible 2 2
Therapeutic or Diagnostic Output Failure 2 2
Difficult to Open or Close 2 2
Connection Problem 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Free or Unrestricted Flow 2 2
Gas/Air Leak 2 2
Air/Gas in Device 2 2
Priming Problem 2 2
Activation Problem 1 1
Separation Problem 1 1
Unexpected Color 1 1
Device Fell 1 1
Inadequate User Interface 1 1
Contamination of Device Ingredient or Reagent 1 1
Device Contamination With Biological Material 1 1
Filtration Problem 1 1
No Apparent Adverse Event 1 1
Output Problem 1 1
Packaging Problem 1 1
Patient Device Interaction Problem 1 1
Application Program Problem: Medication Error 1 1
Failure to Pump 1 1
Shelf Life Exceeded 1 1
Shipping Damage or Problem 1 1
Device Slipped 1 1
Sticking 1 1
Stretched 1 1
Device Inoperable 1 1
Microbial Contamination of Device 1 1
Fitting Problem 1 24
Chemical Spillage 1 1
Device Displays Incorrect Message 1 1
Malposition of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 3131 5239
No Clinical Signs, Symptoms or Conditions 2480 2480
No Consequences Or Impact To Patient 2400 3276
No Known Impact Or Consequence To Patient 1035 2084
No Information 125 125
No Code Available 79 79
Pain 65 65
Insufficient Information 62 62
Nausea 48 48
Numbness 34 34
Foreign Body In Patient 27 27
Tinnitus 24 24
Vomiting 23 23
Overdose 21 21
Fever 19 19
Unspecified Infection 18 18
Dizziness 18 18
Fatigue 17 17
Rash 17 17
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 17 17
Swelling 13 13
Chemical Exposure 13 13
Itching Sensation 12 12
Dyspnea 12 12
Diarrhea 12 12
Device Embedded In Tissue or Plaque 12 12
Injury 11 11
Malaise 10 10
Tachycardia 10 10
Abdominal Pain 10 10
Death 8 8
Inadequate Pain Relief 8 8
Chills 8 8
Missed Dose 8 8
Post Operative Wound Infection 8 8
Underdose 8 8
Lethargy 7 7
Taste Disorder 7 7
Reaction 7 7
Nerve Damage 7 7
High Blood Pressure/ Hypertension 7 7
Seizures 7 7
Low Blood Pressure/ Hypotension 6 6
Headache 6 6
Blurred Vision 6 6
Thromboembolism 5 5
Diaphoresis 5 5
Toxicity 5 5
Chest Pain 5 5
Inflammation 5 5
Necrosis 4 4
Muscle Weakness 4 4
Dysphagia/ Odynophagia 4 4
Pulmonary Embolism 4 4
Sweating 4 4
Confusion/ Disorientation 4 4
Burning Sensation 4 4
Tingling 4 4
Anxiety 4 4
Discomfort 3 3
Ulcer 3 3
Weakness 3 3
Decreased Sensitivity 3 3
Edema 3 3
Erythema 3 3
Peeling 3 3
Partial thickness (Second Degree) Burn 3 3
Test Result 3 3
Swelling/ Edema 2 2
Unspecified Kidney or Urinary Problem 2 2
Blister 2 2
Paralysis 2 2
Pulmonary Edema 2 2
Skin Irritation 2 2
Muscle Spasm(s) 2 2
Hypoglycemia 2 2
Hemorrhage/Bleeding 2 2
Pyrosis/Heartburn 2 2
Fainting 2 2
Fall 2 2
Aneurysm 2 2
Dehydration 2 2
Purulent Discharge 2 2
Bacterial Infection 2 2
Cardiac Arrest 2 2
Shaking/Tremors 2 2
Sleep Dysfunction 2 2
Visual Disturbances 2 2
Hot Flashes/Flushes 2 2
Urticaria 2 2
Urinary Frequency 1 1
Dysphasia 1 1
Arthralgia 1 1
Sedation 1 1
Disability 1 1
Fasciitis 1 1
Impaired Healing 1 1
Seizures, Grand-Mal 1 1
Twitching 1 1
Heart Failure 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Arrow International Inc II Feb-25-2019
2 Leventon S. A. U. II Aug-23-2019
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