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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device epinephrine syringe
Regulation Description Piston syringe.
Definition Intended for intramuscular or subcutaneous injection of epinephrine.
Product CodePQX
Regulation Number 880.5860
Device Class 2

MDR Year MDR Reports MDR Events
2022 1 2
2024 20 21
2025 28 28
2026 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Defective Device 14 15
Failure to Fire 9 9
Failure to Deliver 7 7
Defective Component 6 6
Material Twisted/Bent 5 5
Inaccurate Delivery 5 6
Device Damaged Prior to Use 3 3
Fluid/Blood Leak 3 3
Leak/Splash 2 2
Component Missing 2 2
Self-Activation or Keying 2 2
Break 1 1
Physical Resistance/Sticking 1 1
Short Fill 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Misfire 1 1
Product Quality Problem 1 1
Activation Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 47 49
Hypersensitivity/Allergic reaction 3 3
Needle Stick/Puncture 1 1

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