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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 430 430

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 2411 5118
Filling Problem 2311 2783
Material Rupture 988 1290
No Flow 938 1191
Excess Flow or Over-Infusion 631 631
Infusion or Flow Problem 276 276
Device Contamination with Chemical or Other Material 187 336
Break 158 180
Disconnection 97 97
Adverse Event Without Identified Device or Use Problem 91 91
Leak/Splash 87 87
Component Missing 66 69
Failure to Infuse 65 65
Improper Flow or Infusion 53 53
Crack 52 56
Contamination /Decontamination Problem 44 44
Loose or Intermittent Connection 28 29
Inaccurate Flow Rate 26 26
Detachment of Device or Device Component 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 11 11
Physical Resistance/Sticking 11 11
Pumping Problem 9 9
Improper or Incorrect Procedure or Method 7 7
Obstruction of Flow 7 7
Defective Component 6 6
Material Integrity Problem 6 6
Device Contaminated During Manufacture or Shipping 5 5
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
Material Fragmentation 4 4
Deflation Problem 4 4
Inaccurate Delivery 4 4
Patient-Device Incompatibility 3 3
Degraded 3 3
Priming Problem 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 4203 4203
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 25 25
Foreign Body In Patient 25 25
Tinnitus 21 21
Chemical Exposure 20 20
Malaise 18 18
Vomiting 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
Dyspnea 10 10
Fever 10 10
Overdose 10 10
Inadequate Pain Relief 10 10
Taste Disorder 9 9
High Blood Pressure/ Hypertension 9 9
Chest Pain 9 9
Rash 7 7
Muscle Weakness 6 6
Diaphoresis 6 6
Lethargy 6 6
Swelling/ Edema 5 5
Swelling 5 5
Death 5 5
Bacterial Infection 5 5
Low Blood Pressure/ Hypotension 5 5
Inflammation 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
Pulmonary Embolism 3 3
Hemorrhage/Bleeding 3 3
Edema 3 3
Arrhythmia 3 3
Cardiac Arrest 2 2
Purulent Discharge 2 2
Dysphagia/ Odynophagia 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
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
Convulsion/Seizure 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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