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TPLC
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show TPLC since
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Device
pad, alcohol, device disinfectant
Product Code
LKB
Device Class
Unclassified
Premarket Reviews
Manufacturer
Decision
BECTON DICKINSON & CO.
SUBSTANTIALLY EQUIVALENT
1
CR BARD
SUBSTANTIALLY EQUIVALENT
1
PROFESSIONAL DISPOSABLES INTERNATIONAL, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
6
6
2015
1
1
2016
7
7
2017
43
43
2018
21
21
2019
37
37
2020
39
39
2021
40
40
2022
9
9
2023
29
29
2024
3
3
Device Problems
MDRs with this Device Problem
Events in those MDRs
Device Markings/Labelling Problem
45
45
Device Contamination with Chemical or Other Material
40
40
Defective Component
33
33
Fluid/Blood Leak
28
28
Break
14
14
Use of Device Problem
13
13
Accessory Incompatible
8
8
Missing Information
7
7
Adverse Event Without Identified Device or Use Problem
5
5
Leak/Splash
4
4
Material Integrity Problem
3
3
Contamination
3
3
Product Quality Problem
2
2
Illegible Information
2
2
Patient-Device Incompatibility
2
2
Occlusion Within Device
2
2
Component Missing
2
2
Device Dislodged or Dislocated
2
2
Appropriate Term/Code Not Available
2
2
Physical Resistance/Sticking
2
2
Detachment Of Device Component
2
2
Insufficient Information
2
2
Defective Device
2
2
Manufacturing, Packaging or Shipping Problem
2
2
Entrapment of Device
2
2
Device Alarm System
1
1
Loose or Intermittent Connection
1
1
Moisture or Humidity Problem
1
1
Disconnection
1
1
Fungus in Device Environment
1
1
Packaging Problem
1
1
Detachment of Device or Device Component
1
1
Crack
1
1
Device-Device Incompatibility
1
1
Reflux within Device
1
1
Contamination of Device Ingredient or Reagent
1
1
Inaccurate Information
1
1
Material Separation
1
1
Material Fragmentation
1
1
Separation Failure
1
1
Failure To Unwrap
1
1
Obstruction of Flow
1
1
No Flow
1
1
Contamination /Decontamination Problem
1
1
Chemical Problem
1
1
Expiration Date Error
1
1
Device Operates Differently Than Expected
1
1
Improper or Incorrect Procedure or Method
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
76
76
No Known Impact Or Consequence To Patient
71
71
No Consequences Or Impact To Patient
34
34
No Patient Involvement
14
14
No Information
10
10
Obstruction/Occlusion
6
6
Choking
3
3
Unspecified Infection
3
3
Rash
2
2
Apnea
2
2
Hypersensitivity/Allergic reaction
2
2
Underdose
2
2
Foreign Body In Patient
2
2
Air Embolism
1
1
Airway Obstruction
1
1
Lethargy
1
1
Chemical Exposure
1
1
Blood Loss
1
1
No Code Available
1
1
Insufficient Information
1
1
Hypoglycemia
1
1
Low Blood Pressure/ Hypotension
1
1
Hypoxia
1
1
Bacterial Infection
1
1
Death
1
1
Eye Injury
1
1
Hyperglycemia
1
1
Respiratory Distress
1
1
Swelling
1
1
Anaphylactoid
1
1
Complaint, Ill-Defined
1
1
Diabetic Ketoacidosis
1
1
Reinfusion
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Alere San Diego
II
Nov-16-2011
2
Catheter Connections, Inc.
II
Sep-05-2014
3
MEDLINE INDUSTRIES, LP - Northfield
II
Mar-29-2024
4
Madison Polymeric Engineering
II
May-12-2017
5
Mckesson Medical-Surgical Inc. Corporate Office
II
Aug-26-2022
6
Vygon Corporation
I
Jun-11-2011
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