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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
2017
27
27
2018
65
66
2019
137
144
2020
80
80
2021
130
130
2022
44
44
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fluid Leak
125
125
Leak/Splash
101
101
Break
91
97
Mechanical Problem
83
83
Application Program Problem: Dose Calculation Error
43
43
Output Problem
40
40
Disconnection
38
38
Incorrect, Inadequate or Imprecise Resultor Readings
37
37
Failure to Align
16
16
Defective Component
11
11
Crack
11
11
Improper or Incorrect Procedure or Method
10
10
Device Contamination with Chemical or Other Material
8
10
Improper Flow or Infusion
7
7
Hole In Material
6
6
Component Missing
6
6
Microbial Contamination of Device
5
5
Incorrect Measurement
5
5
Thermal Decomposition of Device
5
5
Contamination
5
5
Material Puncture/Hole
4
4
Device Markings/Labelling Problem
4
4
Material Integrity Problem
4
4
Material Split, Cut or Torn
4
4
Air/Gas in Device
4
4
Material Twisted/Bent
3
3
Adverse Event Without Identified Device or Use Problem
3
3
Expiration Date Error
3
3
Defective Device
3
3
Contamination /Decontamination Problem
3
3
Product Quality Problem
3
3
Device Emits Odor
3
3
Precipitate in Device or Device Ingredient
3
3
Use of Device Problem
3
3
Loose or Intermittent Connection
3
3
Device Alarm System
2
2
Degraded
2
2
Material Opacification
2
2
Application Program Problem: Parameter Calculation Error
2
2
Contamination of Device Ingredient or Reagent
2
2
Device Operates Differently Than Expected
2
2
Device Dislodged or Dislocated
2
2
Pumping Problem
2
2
Inaccurate Information
2
2
Unexpected Color
1
1
Power Problem
1
1
Protective Measures Problem
1
1
Physical Resistance/Sticking
1
1
Unexpected Shutdown
1
1
Application Program Freezes, Becomes Nonfunctional
1
1
Therapeutic or Diagnostic Output Failure
1
1
Data Problem
1
1
Patient Data Problem
1
1
Application Program Problem: Medication Error
1
1
Device Operational Issue
1
1
Difficult to Open or Close
1
1
Compatibility Problem
1
1
Infusion or Flow 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
Application Program Problem
1
1
Calibration Problem
1
1
Unsealed Device Packaging
1
1
Melted
1
1
Misassembled
1
1
Short Fill
1
1
Smoking
1
1
Inaccurate Delivery
1
1
Cut In Material
1
1
No Display/Image
1
1
Defective Alarm
1
1
Labelling, Instructions for Use or Training Problem
1
1
Electrical /Electronic Property Problem
1
1
Filling Problem
1
1
Fracture
1
1
Material Fragmentation
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
149
149
No Clinical Signs, Symptoms or Conditions
149
149
No Patient Involvement
143
150
Insufficient Information
17
17
No Consequences Or Impact To Patient
12
13
No Information
7
7
Hyperglycemia
3
3
Electrolyte Imbalance
2
2
Complaint, Ill-Defined
1
1
Liver Damage/Dysfunction
1
1
Death
1
1
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
HEALTH ROBOTICS S.R.L.
II
Jan-10-2017
4
Smiths Medical ASD Inc.
II
Apr-21-2021
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