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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device infusor, pressure, for i.v. bags
Product CodeKZD
Regulation Number 880.5420
Device Class 1

MDR Year MDR Reports MDR Events
2014 72 72
2015 31 31
2016 4 4
2017 38 38
2018 6 6
2019 4 4
2020 8 8
2021 13 13
2022 45 45
2023 31 31
2024 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Air Leak 109 109
Loss of or Failure to Bond 93 93
Leak/Splash 44 44
Pressure Problem 19 19
Gas/Air Leak 16 16
Decrease in Pressure 14 14
Device Contamination with Chemical or Other Material 12 12
Crack 8 8
Inflation Problem 6 6
Unintended Deflation 6 6
Appropriate Term/Code Not Available 5 5
Missing Value Reason 4 4
Material Integrity Problem 4 4
Device Operates Differently Than Expected 4 4
Mechanical Problem 4 4
Disconnection 4 4
Break 4 4
Burst Container or Vessel 3 3
Fluid/Blood Leak 3 3
Defective Device 3 3
Detachment of Device or Device Component 2 2
Fracture 2 2
Infusion or Flow Problem 2 2
Detachment Of Device Component 2 2
Deflation Problem 2 2
Backflow 2 2
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Insufficient Information 2 2
Device Handling Problem 2 2
Explosion 1 1
Material Split, Cut or Torn 1 1
Incomplete or Inadequate Connection 1 1
Failure to Deflate 1 1
Therapeutic or Diagnostic Output Failure 1 1
Torn Material 1 1
Misassembly by Users 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Air/Gas in Device 1 1
Material Rupture 1 1
Use of Device Problem 1 1
Failure to Zero 1 1
Insufficient Flow or Under Infusion 1 1
Component Missing 1 1
Inaccurate Delivery 1 1
Device Issue 1 1
Obstruction of Flow 1 1
Component Falling 1 1
Contamination 1 1
Improper Flow or Infusion 1 1
Inadequate User Interface 1 1
Device Operational Issue 1 1
Free or Unrestricted Flow 1 1
Material Fragmentation 1 1
No Display/Image 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 109 109
No Clinical Signs, Symptoms or Conditions 69 69
Insufficient Information 25 25
No Consequences Or Impact To Patient 25 25
No Information 6 6
No Code Available 6 6
Missing Value Reason 6 6
Air Embolism 5 5
Low Blood Pressure/ Hypotension 3 3
No Patient Involvement 3 3
Urinary Tract Infection 2 2
Cardiac Arrest 2 2
Death 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Hearing Impairment 1 1
Arrhythmia 1 1
Atrial Fibrillation 1 1
Misdiagnosis 1 1
Sudden Cardiac Death 1 1
Foreign Body In Patient 1 1
Not Applicable 1 1
Embolism/Embolus 1 1
Respiratory Arrest 1 1
Respiratory Insufficiency 1 1

Recalls
Manufacturer Recall Class Date Posted
1 3M Company - Health Care Business II Jun-26-2017
2 GE Healthcare, LLC II Jun-24-2011
3 Merit Medical Systems, Inc. II Dec-14-2009
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