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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, transport, aerobic
Regulation Description Microbiological specimen collection and transport device.
Product CodeJTW
Regulation Number 866.2900
Device Class 1

MDR Year MDR Reports MDR Events
2020 12 12
2021 7 7
2022 5 5
2023 22 22
2024 37 37
2025 37 38
2026 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Short Fill 24 24
Leak/Splash 11 11
Loss of or Failure to Bond 9 9
Incorrect, Inadequate or Imprecise Result or Readings 9 9
Device Markings/Labelling Problem 9 9
Product Quality Problem 8 8
Device Contamination with Chemical or Other Material 7 7
Adverse Event Without Identified Device or Use Problem 6 7
Separation Problem 6 6
Device Ingredient or Reagent Problem 5 5
Premature Separation 4 4
Detachment of Device or Device Component 3 3
Delivered as Unsterile Product 3 3
Material Separation 3 3
Volume Accuracy Problem 3 3
Break 2 2
Contamination 2 2
No Apparent Adverse Event 2 2
Physical Resistance/Sticking 2 2
Insufficient Information 1 1
Device Handling Problem 1 1
Missing Information 1 1
Device Dislodged or Dislocated 1 1
Protective Measures Problem 1 1
Material Deformation 1 1
Material Protrusion/Extrusion 1 1
Material Discolored 1 1
Fracture 1 1
Difficult to Insert 1 1
Off-Label Use 1 1
Partial Blockage 1 1
Microbial Contamination of Device 1 1
Component Missing 1 1
Expiration Date Error 1 1
Contamination /Decontamination Problem 1 1
Use of Device Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 100 100
Needle Stick/Puncture 10 11
No Known Impact Or Consequence To Patient 6 6
Insufficient Information 3 3
No Consequences Or Impact To Patient 2 2
Hypersensitivity/Allergic reaction 1 1
Inflammation 1 1
Blood Loss 1 1
No Patient Involvement 1 1
Hemorrhage/Bleeding 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Copan Italia II Jun-09-2025
2 Hologic, Inc II Mar-11-2022
3 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
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