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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device filter, infusion line
Product CodeFPB
Regulation Number 880.5440
Device Class 2


Premarket Reviews
ManufacturerDecision
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
MERCK MILLIPORE LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 67 67
2015 26 26
2016 95 95
2017 53 53
2018 35 35
2019 31 31
2020 18 18
2021 160 160
2022 36 36
2023 39 39
2024 24 24

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 378 378
Crack 74 74
Leak/Splash 53 53
Disconnection 26 26
Break 15 15
Hole In Material 12 12
No Flow 12 12
Device Contamination with Chemical or Other Material 10 10
Material Puncture/Hole 10 10
Obstruction of Flow 9 9
Improper Flow or Infusion 7 7
Insufficient Information 7 7
Adverse Event Without Identified Device or Use Problem 6 6
Reflux within Device 6 6
Defective Component 5 5
Backflow 5 5
Infusion or Flow Problem 5 5
Defective Device 4 4
Complete Blockage 4 4
Fracture 4 4
Material Separation 4 4
Loose or Intermittent Connection 3 3
Occlusion Within Device 3 3
Device Damaged Prior to Use 3 3
Difficult to Flush 3 3
Air Leak 3 3
Filtration Problem 3 3
Gas/Air Leak 2 2
Detachment of Device or Device Component 2 2
Device Operates Differently Than Expected 2 2
Pressure Problem 2 2
Protective Measures Problem 2 2
Component(s), broken 2 2
Detachment Of Device Component 2 2
Material Discolored 2 2
Insufficient Flow or Under Infusion 2 2
Increase in Pressure 2 2
Failure to Prime 2 2
Nonstandard Device 1 1
Improper or Incorrect Procedure or Method 1 1
Product Quality Problem 1 1
Failure to Deliver 1 1
Tear, Rip or Hole in Device Packaging 1 1
Cut In Material 1 1
Failure to Disconnect 1 1
Separation Failure 1 1
Unintended Ejection 1 1
Restricted Flow rate 1 1
Contamination 1 1
Burst Container or Vessel 1 1
Therapeutic or Diagnostic Output Failure 1 1
Material Integrity Problem 1 1
Mechanics Altered 1 1
Device Packaging Compromised 1 1
Patient-Device Incompatibility 1 1
Chemical Spillage 1 1
Connection Problem 1 1
Contamination of Device Ingredient or Reagent 1 1
Audible Prompt/Feedback Problem 1 1
Priming Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 202 202
No Consequences Or Impact To Patient 171 171
No Known Impact Or Consequence To Patient 133 133
Insufficient Information 18 18
No Information 11 11
No Patient Involvement 8 8
Low Blood Pressure/ Hypotension 8 8
Dyspnea 7 7
Underdose 6 6
Therapeutic Response, Decreased 6 6
Blood Loss 5 5
Abdominal Pain 5 5
Burning Sensation 5 5
Nausea 4 4
Respiratory Distress 3 3
Hot Flashes/Flushes 3 3
Hypoglycemia 3 3
Reaction 3 3
Low Oxygen Saturation 3 3
No Code Available 3 3
Unspecified Infection 2 2
Tachycardia 2 2
Thrombus 1 1
Urinary Retention 1 1
Venipuncture 1 1
Loss of Vision 1 1
Inflammation 1 1
Hypopyon 1 1
Bacterial Infection 1 1
Endophthalmitis 1 1
Hyperglycemia 1 1
High Blood Pressure/ Hypertension 1 1
Hyperthermia 1 1
Patient Problem/Medical Problem 1 1
High Pulmonary Arterial Wedge Pressure 1 1
Therapy/non-surgical treatment, additional 1 1
Unknown (for use when the patient's condition is not known) 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Halyard Health, Inc II Mar-30-2018
2 Pall Life Sciences Puerto Rico Llc II Jun-30-2011
3 Smiths Medical ASD Inc. II Apr-21-2021
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