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TPLC
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Device
container, specimen, sterile
Regulation Description
Specimen transport and storage container.
Product Code
FMH
Regulation Number
864.3250
Device Class
1
MDR Year
MDR Reports
MDR Events
2020
40
40
2021
22
22
2022
20
20
2023
43
43
2024
39
39
2025
46
46
Device Problems
MDRs with this Device Problem
Events in those MDRs
Leak/Splash
44
44
Device Contamination with Chemical or Other Material
41
41
Incorrect, Inadequate or Imprecise Result or Readings
16
16
Short Fill
12
12
Device Markings/Labelling Problem
9
9
Difficult to Remove
9
9
Unsealed Device Packaging
7
7
Overfill
6
6
Tear, Rip or Hole in Device Packaging
6
6
Break
5
5
Contamination
5
5
Fluid/Blood Leak
4
4
Separation Problem
4
4
False Positive Result
4
4
Device Ingredient or Reagent Problem
3
3
Volume Accuracy Problem
3
3
Separation Failure
3
3
Component Missing
3
3
Activation, Positioning or Separation Problem
2
2
Compatibility Problem
2
2
Defective Device
2
2
Material Discolored
2
2
Fracture
2
2
Material Separation
2
2
Incorrect Measurement
2
2
Failure to Seal
1
1
No Device Output
1
1
Improper or Incorrect Procedure or Method
1
1
Connection Problem
1
1
Nonstandard Device
1
1
Coagulation in Device or Device Ingredient
1
1
Appropriate Term/Code Not Available
1
1
Protective Measures Problem
1
1
Device Dislodged or Dislocated
1
1
Device Handling Problem
1
1
Packaging Problem
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Infusion or Flow Problem
1
1
Material Twisted/Bent
1
1
Use of Device Problem
1
1
Difficult to Insert
1
1
Contamination /Decontamination Problem
1
1
Defective Component
1
1
Insufficient Information
1
1
Filling Problem
1
1
Crack
1
1
Device Contaminated During Manufacture or Shipping
1
1
Device-Device Incompatibility
1
1
Fitting Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
159
159
No Consequences Or Impact To Patient
17
17
No Known Impact Or Consequence To Patient
16
16
Insufficient Information
8
8
No Patient Involvement
6
6
Hypersensitivity/Allergic reaction
2
2
Exposure to Body Fluids
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
No Code Available
1
1
Rash
1
1
Needle Stick/Puncture
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Centurion Medical Products Corporation
II
Feb-05-2020
2
Klinika Mdical Gmb
II
May-15-2025
3
MEDLINE INDUSTRIES, LP - Northfield
II
Sep-06-2024
4
MEDLINE INDUSTRIES, LP - Northfield
II
Mar-29-2024
5
MEDLINE INDUSTRIES, LP - Northfield
II
Aug-03-2023
6
MEDLINE INDUSTRIES, LP - Northfield
II
Feb-06-2023
7
Meridian Bioscience Inc
II
Dec-08-2023
8
Thermo Fisher Scientific (Monterrey)
II
May-26-2020
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