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TPLC
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Device
system/device, pharmacy compounding
Product Code
NEP
Regulation Number
880.5440
Device Class
2
MDR Year
MDR Reports
MDR Events
2018
65
66
2019
137
144
2020
80
80
2021
130
130
2022
78
78
2023
11
11
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fluid/Blood Leak
133
133
Leak/Splash
102
102
Break
93
99
Mechanical Problem
83
83
Application Program Problem: Dose Calculation Error
46
46
Output Problem
41
41
Disconnection
37
37
Incorrect, Inadequate or Imprecise Result or Readings
37
37
Failure to Align
18
18
Defective Component
11
11
Crack
11
11
Contamination
8
8
Device Contamination with Chemical or Other Material
8
10
Improper Flow or Infusion
7
7
Component Missing
7
7
Improper or Incorrect Procedure or Method
7
7
Loose or Intermittent Connection
6
6
Incorrect Measurement
5
5
Thermal Decomposition of Device
5
5
Microbial Contamination of Device
5
5
Adverse Event Without Identified Device or Use Problem
5
5
Air/Gas in Device
4
4
Material Split, Cut or Torn
4
4
Material Puncture/Hole
4
4
Device Markings/Labelling Problem
4
4
Precipitate in Device or Device Ingredient
4
4
Device Emits Odor
3
3
Device Alarm System
3
3
Hole In Material
3
3
Material Integrity Problem
3
3
Material Twisted/Bent
3
3
Use of Device Problem
3
3
Expiration Date Error
3
3
Defective Device
3
3
Contamination /Decontamination Problem
3
3
Contamination of Device Ingredient or Reagent
3
3
Tear, Rip or Hole in Device Packaging
2
2
Device Dislodged or Dislocated
2
2
Labelling, Instructions for Use or Training Problem
2
2
Degraded
2
2
Material Opacification
2
2
Corroded
2
2
Application Program Problem: Parameter Calculation Error
2
2
Pumping Problem
2
2
Therapeutic or Diagnostic Output Failure
2
2
Data Problem
2
2
Application Program Problem: Medication Error
2
2
Inaccurate Information
2
2
Unexpected Color
1
1
Physical Resistance/Sticking
1
1
Unexpected Shutdown
1
1
Application Program Freezes, Becomes Nonfunctional
1
1
Device Difficult to Program or Calibrate
1
1
Material Rupture
1
1
Short Fill
1
1
Smoking
1
1
Unsealed Device Packaging
1
1
Melted
1
1
Misassembled
1
1
Nonstandard Device
1
1
Use of Incorrect Control/Treatment Settings
1
1
Defective Alarm
1
1
Fracture
1
1
Material Fragmentation
1
1
No Display/Image
1
1
Electrical /Electronic Property Problem
1
1
Filling Problem
1
1
Free or Unrestricted Flow
1
1
Human-Device Interface Problem
1
1
Device Operates Differently Than Expected
1
1
Device Operational Issue
1
1
Difficult to Open or Close
1
1
Power Problem
1
1
Protective Measures Problem
1
1
Compatibility Problem
1
1
Infusion or Flow Problem
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Material Deformation
1
1
Detachment of Device or Device Component
1
1
Communication or Transmission Problem
1
1
Device Displays Incorrect Message
1
1
Calibration Problem
1
1
Product Quality Problem
1
1
Inaccurate Delivery
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
188
188
No Known Impact Or Consequence To Patient
145
145
No Patient Involvement
125
132
Insufficient Information
19
19
No Consequences Or Impact To Patient
12
13
No Information
6
6
Hyperglycemia
5
5
Electrolyte Imbalance
3
3
Dehydration
1
1
No Code Available
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
B Braun Medical, Inc.
II
Dec-23-2020
2
B. Braun Medical, Inc.
II
Jul-03-2018
3
Baxter Healthcare Corporation
I
Jul-22-2022
4
Smiths Medical ASD Inc.
II
Apr-21-2021
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