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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
12
12
Device Problems
MDRs with this Device Problem
Events in those MDRs
Leak/Splash
37
37
Device Contamination with Chemical or Other Material
28
28
Incorrect, Inadequate or Imprecise Result or Readings
14
14
Short Fill
10
10
Difficult to Remove
9
9
Unsealed Device Packaging
7
7
Device Markings/Labelling Problem
6
6
Tear, Rip or Hole in Device Packaging
6
6
Break
5
5
Contamination
5
5
Separation Problem
4
4
Fluid/Blood Leak
4
4
Overfill
4
4
False Positive Result
3
3
Volume Accuracy Problem
3
3
Device Ingredient or Reagent Problem
3
3
Component Missing
3
3
Separation Failure
3
3
Activation, Positioning or Separation Problem
2
2
Compatibility Problem
2
2
Incorrect Measurement
2
2
Material Separation
2
2
Defective Device
2
2
Fracture
2
2
Connection Problem
1
1
Device Contaminated During Manufacture or Shipping
1
1
Nonstandard Device
1
1
Protective Measures Problem
1
1
Contamination /Decontamination Problem
1
1
Fitting Problem
1
1
Device Dislodged or Dislocated
1
1
Infusion or Flow Problem
1
1
Difficult to Insert
1
1
Defective Component
1
1
No Device Output
1
1
Material Twisted/Bent
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Material Discolored
1
1
Insufficient Information
1
1
Improper or Incorrect Procedure or Method
1
1
Coagulation in Device or Device Ingredient
1
1
Device-Device Incompatibility
1
1
Filling Problem
1
1
Failure to Seal
1
1
Crack
1
1
Appropriate Term/Code Not Available
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
125
125
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
No Code Available
1
1
Rash
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Needle Stick/Puncture
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Centurion Medical Products Corporation
II
Feb-05-2020
2
MEDLINE INDUSTRIES, LP - Northfield
II
Sep-06-2024
3
MEDLINE INDUSTRIES, LP - Northfield
II
Mar-29-2024
4
MEDLINE INDUSTRIES, LP - Northfield
II
Aug-03-2023
5
MEDLINE INDUSTRIES, LP - Northfield
II
Feb-06-2023
6
Meridian Bioscience Inc
II
Dec-08-2023
7
Thermo Fisher Scientific (Monterrey)
II
May-26-2020
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