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TPLC
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show TPLC since
2009
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2024
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Device
infusor, pressure, for i.v. bags
Product Code
KZD
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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