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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device device, gas generating
Product CodeKZJ
Regulation Number 866.2580
Device Class 1

MDR Year MDR Reports MDR Events
2017 1 1
2018 1 1
2019 1 1
2021 4 4
2022 3 3
2023 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 5 5
Contamination 2 2
Fracture 2 2
Contamination of Device Ingredient or Reagent 2 2
Device Markings/Labelling Problem 2 2
Break 1 1
Defective Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 11 11
Laceration(s) 2 2
Injury 1 1
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Becton Dickinson & Co. II Nov-26-2010
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