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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
2019 974 4421
2020 2731 3223
2021 1802 1802
2022 1288 1288
2023 1249 1249
2024 558 558

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 2441 5148
Filling Problem 2345 2817
Material Rupture 995 1297
No Flow 958 1211
Excess Flow or Over-Infusion 650 650
Infusion or Flow Problem 276 276
Device Contamination with Chemical or Other Material 189 338
Break 161 183
Disconnection 98 98
Leak/Splash 92 92
Adverse Event Without Identified Device or Use Problem 92 92
Component Missing 66 69
Failure to Infuse 65 65
Crack 53 57
Improper Flow or Infusion 53 53
Contamination /Decontamination Problem 44 44
Detachment of Device or Device Component 31 31
Loose or Intermittent Connection 28 29
Inaccurate Flow Rate 26 26
Insufficient Flow or Under Infusion 25 25
Material Split, Cut or Torn 23 24
Backflow 18 18
Failure to Deliver 15 15
Material Twisted/Bent 15 15
Material Deformation 14 14
Physical Resistance/Sticking 11 11
Failure to Prime 11 11
Pumping Problem 9 9
Improper or Incorrect Procedure or Method 8 8
Obstruction of Flow 7 7
Material Integrity Problem 6 6
Defective Component 6 6
Fracture 5 5
Material Puncture/Hole 5 8
Use of Device Problem 5 5
Material Separation 5 5
Device Contaminated During Manufacture or Shipping 5 5
Air/Gas in Device 5 5
Defective Device 5 5
Inaccurate Delivery 4 4
Material Fragmentation 4 4
Deflation Problem 4 4
Therapeutic or Diagnostic Output Failure 3 3
Degraded 3 3
Priming Problem 3 3
Patient-Device Incompatibility 3 3
Scratched Material 3 3
Device Damaged Prior to Use 2 2
Insufficient Information 2 2
Application Program Problem: Medication Error 2 2
Reflux within Device 2 2
Burst Container or Vessel 2 2
Precipitate in Device or Device Ingredient 2 2
Misconnection 2 2
Product Quality Problem 2 2
Activation Problem 2 2
Shipping Damage or Problem 2 2
Appropriate Term/Code Not Available 2 2
Melted 2 2
Inadequate Instructions for Healthcare Professional 1 1
Difficult to Open or Close 1 1
No Apparent Adverse Event 1 1
Particulates 1 1
Failure to Eject 1 1
Device Dislodged or Dislocated 1 1
Failure to Pump 1 1
Failure to Reset 1 1
Delivered as Unsterile Product 1 4
Increase in Pressure 1 1
Material Discolored 1 1
Inflation Problem 1 1
Gas/Air Leak 1 1
Human-Device Interface Problem 1 1
Fitting Problem 1 24
Unexpected Color 1 1
Partial Blockage 1 1
Mechanical Jam 1 1
Complete Blockage 1 1
Material Opacification 1 1
Inadequate or Insufficient Training 1 1
Patient Device Interaction Problem 1 1
Off-Label Use 1 1
Filtration Problem 1 1
Inadequate User Interface 1 1
Microbial Contamination of Device 1 1
Material Perforation 1 1
Output Problem 1 1
Restricted Flow rate 1 1
Malposition of Device 1 1
Moisture Damage 1 1
Positioning Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4327 4327
No Patient Involvement 1894 3974
No Consequences Or Impact To Patient 1428 2260
No Known Impact Or Consequence To Patient 413 1440
Insufficient Information 146 146
Pain 54 54
Nausea 43 43
Numbness 34 34
No Code Available 33 33
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 26 26
Foreign Body In Patient 25 25
Chemical Exposure 22 22
Tinnitus 21 21
Vomiting 18 18
Malaise 18 18
Discomfort 16 16
Fatigue 15 15
Abdominal Pain 14 14
Dizziness 14 14
No Information 13 13
Tachycardia 12 12
Hot Flashes/Flushes 11 11
Diarrhea 11 11
Fever 11 11
Dyspnea 10 10
Overdose 10 10
Inadequate Pain Relief 10 10
Taste Disorder 9 9
Chest Pain 9 9
High Blood Pressure/ Hypertension 9 9
Rash 7 7
Muscle Weakness 6 6
Swelling/ Edema 6 6
Diaphoresis 6 6
Lethargy 6 6
Swelling 5 5
Low Blood Pressure/ Hypotension 5 5
Inflammation 5 5
Death 5 5
Bacterial Infection 5 5
Blurred Vision 4 4
Chills 4 4
Burning Sensation 4 4
Nerve Damage 4 4
Underdose 4 4
Thromboembolism 4 4
Anxiety 4 4
Reaction 3 3
Device Embedded In Tissue or Plaque 3 3
Missed Dose 3 3
Unspecified Kidney or Urinary Problem 3 3
Peeling 3 3
Arrhythmia 3 3
Purulent Discharge 3 3
Pulmonary Embolism 3 3
Hemorrhage/Bleeding 3 3
Edema 3 3
Erythema 2 2
Fall 2 2
Dysphagia/ Odynophagia 2 2
Cardiac Arrest 2 2
Seizures 2 2
Necrosis 2 2
Hematoma 2 2
Muscle Spasm(s) 2 2
Weakness 2 2
Tingling 2 2
Cramp(s) /Muscle Spasm(s) 2 2
Syncope/Fainting 2 2
Blister 2 2
Alteration in Body Temperature 2 2
Balance Problems 2 2
Foreign Body Embolism 2 2
Cough 2 2
Shaking/Tremors 2 2
Sleep Dysfunction 2 2
Partial thickness (Second Degree) Burn 2 2
Test Result 2 2
Decreased Sensitivity 2 2
Confusion/ Disorientation 2 2
Sweating 2 2
Ulcer 2 2
Injury 1 1
Arthralgia 1 1
Heart Failure 1 1
Rupture 1 1
Therapeutic Response, Decreased 1 1
Chest Tightness/Pressure 1 1
Low Oxygen Saturation 1 1
Disability 1 1
Impaired Healing 1 1
Ambulation Difficulties 1 1
Caustic/Chemical Burns 1 1
Ptosis 1 1
Gastrointestinal Hemorrhage 1 1
Unspecified Gastrointestinal Problem 1 1
Hyponatremia 1 1
Thrombosis/Thrombus 1 1
Heart Failure/Congestive Heart Failure 1 1
Pericarditis 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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