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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-selective and non-differential
Product CodeJSG
Regulation Number 866.2300
Device Class 1

MDR Year MDR Reports MDR Events
2019 25 25
2020 1 1
2021 177 177
2022 198 198
2023 175 175

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 251 251
Contamination 184 184
Contamination of Device Ingredient or Reagent 53 53
Device Markings/Labelling Problem 40 40
Microbial Contamination of Device 17 17
Device Contamination with Chemical or Other Material 11 11
Missing Information 5 5
Contamination /Decontamination Problem 3 3
False Negative Result 3 3
Fluid/Blood Leak 3 3
False Positive Result 2 2
Material Opacification 2 2
Output Problem 2 2
Protective Measures Problem 1 1
Separation Problem 1 1
Inaccurate Information 1 1
Break 1 1
Particulates 1 1
Product Quality Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Leak/Splash 1 1
Connection Problem 1 1
Component Missing 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 539 539
No Known Impact Or Consequence To Patient 21 21
No Consequences Or Impact To Patient 11 11
No Patient Involvement 7 7
Insufficient Information 4 4
Bacterial Infection 2 2
Unspecified Infection 1 1
Injury 1 1
Prolapse 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Becton Dickinson & Co. II Nov-30-2018
2 Remel Inc II May-22-2019
3 Remel Inc II May-20-2019
4 Remel Inc II Sep-07-2018
5 Vectornate USA Inc II Apr-13-2021
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