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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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 782 782

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 2502 5209
Filling Problem 2402 2874
Material Rupture 1003 1305
No Flow 994 1247
Excess Flow or Over-Infusion 681 681
Infusion or Flow Problem 276 276
Device Contamination with Chemical or Other Material 199 348
Break 171 193
Disconnection 99 99
Leak/Splash 93 93
Adverse Event Without Identified Device or Use Problem 93 93
Component Missing 66 69
Failure to Infuse 65 65
Improper Flow or Infusion 57 57
Crack 56 60
Contamination /Decontamination Problem 44 44
Detachment of Device or Device Component 36 36
Loose or Intermittent Connection 29 30
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
Failure to Prime 12 12
Physical Resistance/Sticking 11 11
Pumping Problem 9 9
Improper or Incorrect Procedure or Method 8 8
Obstruction of Flow 7 7
Device Contaminated During Manufacture or Shipping 7 7
Material Integrity Problem 6 6
Defective Component 6 6
Defective Device 5 5
Use of Device Problem 5 5
Material Separation 5 5
Fracture 5 5
Material Puncture/Hole 5 8
Air/Gas in Device 5 5
Priming Problem 4 4
Material Fragmentation 4 4
Deflation Problem 4 4
Inaccurate Delivery 4 4
Patient-Device Incompatibility 3 3
Degraded 3 3
Scratched Material 3 3
Therapeutic or Diagnostic Output Failure 3 3
Insufficient Information 2 2
Appropriate Term/Code Not Available 2 2
Application Program Problem: Medication Error 2 2
Activation Problem 2 2
Burst Container or Vessel 2 2
Product Quality Problem 2 2
Reflux within Device 2 2
Precipitate in Device or Device Ingredient 2 2
Melted 2 2
Misconnection 2 2
Device Damaged Prior to Use 2 2
Shipping Damage or Problem 2 2
Inadequate or Insufficient Training 1 1
Off-Label Use 1 1
Failure to Pump 1 1
Malposition of Device 1 1
Microbial Contamination of Device 1 1
Fitting Problem 1 24
Material Perforation 1 1
Difficult to Open or Close 1 1
Device Dislodged or Dislocated 1 1
Filtration Problem 1 1
Inadequate User Interface 1 1
Gas/Air Leak 1 1
Human-Device Interface Problem 1 1
Moisture Damage 1 1
Delivered as Unsterile Product 1 4
Material Opacification 1 1
Particulates 1 1
Increase in Pressure 1 1
Inadequate Instructions for Healthcare Professional 1 1
Failure to Reset 1 1
Complete Blockage 1 1
Partial Blockage 1 1
Material Discolored 1 1
Inflation Problem 1 1
Restricted Flow rate 1 1
Unexpected Color 1 1
Patient Device Interaction Problem 1 1
Mechanical Jam 1 1
Failure to Eject 1 1
No Apparent Adverse Event 1 1
Output Problem 1 1
Positioning Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4537 4537
No Patient Involvement 1894 3974
No Consequences Or Impact To Patient 1428 2260
No Known Impact Or Consequence To Patient 413 1440
Insufficient Information 149 149
Pain 54 54
Nausea 48 48
Numbness 34 34
No Code Available 33 33
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 26 26
Foreign Body In Patient 26 26
Chemical Exposure 22 22
Tinnitus 21 21
Malaise 19 19
Vomiting 18 18
Discomfort 16 16
Dizziness 15 15
Fatigue 15 15
Abdominal Pain 14 14
No Information 13 13
Tachycardia 12 12
Hot Flashes/Flushes 11 11
Diarrhea 11 11
Dyspnea 11 11
Fever 11 11
Taste Disorder 11 11
Inadequate Pain Relief 10 10
Overdose 10 10
High Blood Pressure/ Hypertension 9 9
Chest Pain 9 9
Rash 7 7
Lethargy 7 7
Diaphoresis 6 6
Swelling/ Edema 6 6
Muscle Weakness 6 6
Swelling 5 5
Blurred Vision 5 5
Death 5 5
Bacterial Infection 5 5
Low Blood Pressure/ Hypotension 5 5
Inflammation 5 5
Chills 4 4
Burning Sensation 4 4
Nerve Damage 4 4
Anxiety 4 4
Underdose 4 4
Thromboembolism 4 4
Device Embedded In Tissue or Plaque 3 3
Shaking/Tremors 3 3
Missed Dose 3 3
Reaction 3 3
Unspecified Kidney or Urinary Problem 3 3
Peeling 3 3
Pulmonary Embolism 3 3
Hemorrhage/Bleeding 3 3
Edema 3 3
Arrhythmia 3 3
Purulent Discharge 3 3
Dysphagia/ Odynophagia 2 2
Cardiac Arrest 2 2
Erythema 2 2
Fall 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
Salivary Hypersecretion 2 2
Unspecified Gastrointestinal Problem 2 2
Blister 2 2
Alteration in Body Temperature 2 2
Balance Problems 2 2
Foreign Body Embolism 2 2
Syncope/Fainting 2 2
Cough 2 2
Sweating 2 2
Ulcer 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
Ambulation Difficulties 1 1
Caustic/Chemical Burns 1 1
Ptosis 1 1
Injury 1 1
Arthralgia 1 1
Heart Failure 1 1
Rupture 1 1
Peritonitis 1 1
Therapeutic Response, Decreased 1 1
Chest Tightness/Pressure 1 1
Low Oxygen Saturation 1 1
Disability 1 1
Impaired Healing 1 1
Gastrointestinal Hemorrhage 1 1
Peripheral Nervous Injury 1 1
Thrombosis/Thrombus 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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