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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device culture media, non-propagating transport
Product CodeJSM
Regulation Number 866.2390
Device Class 1


Premarket Reviews
ManufacturerDecision
ARX SCIENCES, INC.
  SUBSTANTIALLY EQUIVALENT 1
AZER SCIENTIFIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOTEKE CORPORATION (WUXI) CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
COPAN ITALIA S.P.A.
  SUBSTANTIALLY EQUIVALENT 3
GREINER BIO-ONE NA INC.
  SUBSTANTIALLY EQUIVALENT 1
HANGZHOU GENESIS BIODETECTION & BIOCONTROL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HUACHENYANG (SHENZHEN) TECHNOLOGY CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL CHEMICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
MEDSCHENKER, INC.
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC
  SUBSTANTIALLY EQUIVALENT 1
PURITAN MEDICAL PRODUCTS LLC
  SUBSTANTIALLY EQUIVALENT 4
SHENZHEN DAKEWE BIO-ENGINEERING CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
WUXI NEST BIOTECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZHEJIANG GONGDONG MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 2 2
2015 1 1
2016 6 6
2017 57 57
2018 131 131
2019 81 81
2020 47 47
2021 41 41
2022 36 36
2023 48 48
2024 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 63 63
Incorrect, Inadequate or Imprecise Result or Readings 58 58
Material Protrusion/Extrusion 39 39
Short Fill 30 30
Break 28 28
Fluid/Blood Leak 24 24
Volume Accuracy Problem 23 23
Delivered as Unsterile Product 20 20
Incorrect Or Inadequate Test Results 19 19
Device Markings/Labelling Problem 17 17
Device Contamination with Chemical or Other Material 15 15
Product Quality Problem 14 14
Component Missing 13 13
Detachment Of Device Component 12 12
Adverse Event Without Identified Device or Use Problem 8 8
Separation Problem 8 8
Improper or Incorrect Procedure or Method 7 7
Material Separation 6 6
Device Operates Differently Than Expected 6 6
Contamination /Decontamination Problem 5 5
Insufficient Information 5 5
Unsealed Device Packaging 5 5
Contamination 5 5
Appropriate Term/Code Not Available 4 4
Overfill 4 4
Physical Resistance/Sticking 4 4
Detachment of Device or Device Component 4 4
Device Ingredient or Reagent Problem 4 4
Missing Information 3 3
Complete Blockage 3 3
Material Discolored 3 3
False Positive Result 3 3
Difficult to Insert 3 3
Use of Device Problem 3 3
Microbial Contamination of Device 2 2
Sticking 2 2
Material Puncture/Hole 2 2
Bent 2 2
Loose or Intermittent Connection 2 2
Crack 2 2
Premature Separation 2 2
Packaging Problem 2 2
Material Deformation 2 2
Device Packaging Compromised 2 2
Tear, Rip or Hole in Device Packaging 2 2
Contamination of Device Ingredient or Reagent 1 1
Structural Problem 1 1
Defective Device 1 1
Device Or Device Fragments Location Unknown 1 1
Patient-Device Incompatibility 1 1
Difficult to Open or Close 1 1
Device Dislodged or Dislocated 1 1
Fail-Safe Problem 1 1
Flare or Flash 1 1
Torn Material 1 1
Material Twisted/Bent 1 1
Noise, Audible 1 1
Misassembly During Maintenance/Repair 1 1
Coagulation in Device or Device Ingredient 1 1
Filling Problem 1 1
False Negative Result 1 1
Mechanical Problem 1 1
Nonstandard Device 1 1
Hole In Material 1 1
Material Opacification 1 1
Shipping Damage or Problem 1 1
Difficult to Remove 1 1
Suction Problem 1 1
Defective Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 195 195
No Clinical Signs, Symptoms or Conditions 114 114
Needle Stick/Puncture 54 54
No Consequences Or Impact To Patient 43 43
Foreign Body In Patient 12 12
No Information 11 11
No Patient Involvement 7 7
Exposure to Body Fluids 6 6
Insufficient Information 6 6
No Code Available 2 2
Blood Loss 2 2
Chemical Exposure 1 1
Pain 1 1
Discomfort 1 1
Reaction 1 1
Patient Problem/Medical Problem 1 1
Test Result 1 1

Recalls
Manufacturer Recall Class Date Posted
1 American Contract Systems, Inc. II Oct-08-2022
2 American Contract Systems, Inc. I Jul-01-2022
3 Becton Dickinson & Company III Mar-08-2010
4 Gentueri Inc II Feb-04-2022
5 Gentueri Inc II Jan-18-2022
6 Hardy Diagnostics II Dec-21-2020
7 Krishe Inc II Apr-13-2021
8 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
9 Merit Medical Systems, Inc. II Nov-16-2020
10 Remel, Inc II Mar-15-2010
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