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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device clinical sample concentrator
Product CodeJJH
Regulation Number 862.2310
Device Class 1

MDR Year MDR Reports MDR Events
2019 10 10
2020 12 12
2021 20 20
2022 45 45
2023 10 10
2024 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Suction Failure 21 21
Unintended Movement 10 10
False Positive Result 10 10
Contamination 9 9
Fluid/Blood Leak 9 9
Leak/Splash 6 6
Contamination /Decontamination Problem 4 4
Contamination of Device Ingredient or Reagent 4 4
Improper or Incorrect Procedure or Method 4 4
Low Sensing Threshold 4 4
Incorrect, Inadequate or Imprecise Result or Readings 3 3
Use of Device Problem 3 3
Pressure Problem 2 2
False Negative Result 2 2
Mechanical Problem 2 2
Device Fell 2 2
Failure to Transmit Record 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Human-Device Interface Problem 2 2
Electrical /Electronic Property Problem 2 2
Failure to Read Input Signal 1 1
Break 1 1
Device Damaged Prior to Use 1 1
Short Fill 1 1
Defective Component 1 1
Microbial Contamination of Device 1 1
Degraded 1 1
Unable to Obtain Readings 1 1
Positioning Failure 1 1
Failure to Align 1 1
Failure to Back-Up 1 1
Mechanics Altered 1 1
Device Dislodged or Dislocated 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 83 83
No Known Impact Or Consequence To Patient 7 7
Misdiagnosis 3 3
Abrasion 3 3
Chemical Exposure 3 3
Injury 2 2
No Patient Involvement 2 2
Nausea 1 1
Dizziness 1 1
Bone Fracture(s) 1 1
Exposure to Body Fluids 1 1
Insufficient Information 1 1
Laceration(s) 1 1
No Consequences Or Impact To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Becton Dickinson & Co. II Aug-22-2019
2 Entopsis , Inc. II Mar-29-2023
3 Qiagen Sciences LLC II Jul-12-2024
4 Qiagen Sciences LLC II Apr-10-2024
5 Qiagen Sciences LLC II Sep-15-2022
6 Qiagen Sciences LLC II Aug-21-2019
7 Qiagen Sciences LLC I Aug-01-2019
8 Qvella Corporation II Dec-07-2022
9 Roche Molecular Systems, Inc. II Jul-10-2020
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