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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
HANGZHOU QIANTANG LONGYUE BIOTECHNOLOGY CO., LTD
  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 34 34

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 382 382
Crack 75 75
Leak/Splash 57 57
Disconnection 26 26
Break 15 15
No Flow 12 12
Hole In Material 12 12
Material Puncture/Hole 10 10
Device Contamination with Chemical or Other Material 10 10
Obstruction of Flow 9 9
Improper Flow or Infusion 7 7
Insufficient Information 7 7
Reflux within Device 6 6
Adverse Event Without Identified Device or Use Problem 6 6
Backflow 5 5
Defective Component 5 5
Infusion or Flow Problem 5 5
Complete Blockage 4 4
Fracture 4 4
Material Separation 4 4
Defective Device 4 4
Filtration Problem 4 4
Loose or Intermittent Connection 3 3
Difficult to Flush 3 3
Device Damaged Prior to Use 3 3
Air Leak 3 3
Occlusion Within Device 3 3
Failure to Prime 2 2
Detachment of Device or Device Component 2 2
Protective Measures Problem 2 2
Component(s), broken 2 2
Detachment Of Device Component 2 2
Insufficient Flow or Under Infusion 2 2
Increase in Pressure 2 2
Device Operates Differently Than Expected 2 2
Material Discolored 2 2
Pressure Problem 2 2
Gas/Air Leak 2 2
Priming Problem 1 1
Nonstandard Device 1 1
Connection Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Unintended Ejection 1 1
Failure to Disconnect 1 1
Chemical Spillage 1 1
Device Packaging Compromised 1 1
Contamination 1 1
Failure to Deliver 1 1
Separation Failure 1 1
Patient-Device Incompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 211 211
No Consequences Or Impact To Patient 171 171
No Known Impact Or Consequence To Patient 133 133
Insufficient Information 19 19
No Information 11 11
No Patient Involvement 8 8
Low Blood Pressure/ Hypotension 8 8
Dyspnea 7 7
Therapeutic Response, Decreased 6 6
Underdose 6 6
Abdominal Pain 5 5
Blood Loss 5 5
Burning Sensation 5 5
Nausea 4 4
Respiratory Distress 3 3
No Code Available 3 3
Hypoglycemia 3 3
Reaction 3 3
Tachycardia 3 3
Hot Flashes/Flushes 3 3
Low Oxygen Saturation 3 3
High Blood Pressure/ Hypertension 2 2
Unspecified Infection 2 2
Patient Problem/Medical Problem 1 1
Hypopyon 1 1
Venipuncture 1 1
High Pulmonary Arterial Wedge Pressure 1 1
Therapy/non-surgical treatment, additional 1 1
Endophthalmitis 1 1
Inflammation 1 1
Fever 1 1
Urinary Retention 1 1
Hyperglycemia 1 1
Hyperthermia 1 1
Bacterial Infection 1 1
Loss of Vision 1 1
Thrombus 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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