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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device container, specimen, non-sterile
Regulation Description Specimen transport and storage container.
Product CodeNNI
Regulation Number 864.3250
Device Class 1

MDR Year MDR Reports MDR Events
2020 5 5
2021 4 4
2022 3 3
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Crack 4 4
Leak/Splash 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Device Markings/Labelling Problem 1 1
Contamination 1 1
Unintended Ejection 1 1
Connection Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3 3
No Known Impact Or Consequence To Patient 3 3
Insufficient Information 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Hematoma 2 2
Chemical Exposure 1 1
Injury 1 1
Great Vessel Perforation 1 1
Bacterial Infection 1 1
Hemorrhage/Bleeding 1 1
Low Blood Pressure/ Hypotension 1 1
Bruise/Contusion 1 1

Recalls
Manufacturer Recall Class Date Posted
1 MEDLINE INDUSTRIES, LP - Northfield II Feb-18-2022
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