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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device container, i.v.
Regulation Description I.V. container.
Product CodeKPE
Regulation Number 880.5025
Device Class 2


Premarket Reviews
ManufacturerDecision
HAEMOTRONIC, SPA ADVANCED MEDICAL TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
VALMED SRL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 543 543
2016 527 527
2017 284 284
2018 142 142
2019 204 204
2020 114 114

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid Leak 720 720
Device Contamination with Chemical or Other Material 540 540
Bag 229 229
Port 167 167
Leak/Splash 136 136
Contamination /Decontamination Problem 124 124
Hole In Material 81 81
Break 63 63
Seal 59 59
Disconnection 55 55
Particulates 22 22
Tube 19 19
Cap 18 18
Cut In Material 17 17
Failure to Disconnect 17 17
Material Rupture 12 12
Crack 11 11
Detachment of Device or Device Component 7 7
Device Operates Differently Than Expected 6 6
Degraded 6 6
Clamp 6 6
Loose or Intermittent Connection 6 6
Connection Problem 6 6
Improper or Incorrect Procedure or Method 5 5
Material Deformation 5 5
Material Integrity Problem 5 5
Mechanical Problem 5 5
Difficult to Open or Close 5 5
Microbial Contamination of Device 5 5
Material Split, Cut or Torn 5 5
Tip 4 4
Suction Problem 4 4
Air Eliminator 4 4
Device Damaged Prior to Use 4 4
Failure to Infuse 4 4
Tear, Rip or Hole in Device Packaging 4 4
Connector 4 4
Detachment Of Device Component 4 4
Decrease in Suction 4 4
Component Falling 3 3
Contamination 3 3
Material Puncture/Hole 3 3
Material Separation 2 2
Material Perforation 2 2
Defective Device 2 2
Improper Flow or Infusion 2 2
No Flow 2 2
Kinked 2 2
Partial Blockage 2 2
Defective Component 2 2
Improper Chemical Reaction 2 2
Device Fell 2 2
Adverse Event Without Identified Device or Use Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Device Disinfection Or Sterilization Issue 1 1
Device Markings/Labelling Problem 1 1
Fitting Problem 1 1
Inadequacy of Device Shape and/or Size 1 1
Device Inoperable 1 1
Misassembled 1 1
Misconnection 1 1
Moisture Damage 1 1
Product Quality Problem 1 1
Material Discolored 1 1
Holder 1 1
Sediment, Precipitate Or Deposit In Device Or Device Ingredient 1 1
Device Dislodged or Dislocated 1 1
Component Missing 1 1
Obstruction of Flow 1 1
Device Slipped 1 1
Problem with Sterilization 1 1
Retraction Problem 1 1
Nonstandard Device 1 1
Device Emits Odor 1 1
Unsealed Device Packaging 1 1
Precipitate in Device or Device Ingredient 1 1
Failure to Prime 1 1
Material Fragmentation 1 1
Reservoir 1 1
Membrane 1 1
Burst Container or Vessel 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 1482 1482
No Known Impact Or Consequence To Patient 178 178
No Consequences Or Impact To Patient 118 118
No Information 21 21
No Code Available 3 3
No Clinical Signs, Symptoms or Conditions 3 3
Injury 2 2
Death 2 2
Diarrhea 1 1
Headache 1 1
Incontinence 1 1
Unspecified Infection 1 1
Nausea 1 1
Vomiting 1 1
Tingling 1 1
Complaint, Ill-Defined 1 1
Chemical Exposure 1 1
Weight Changes 1 1
Exposure to Body Fluids 1 1
Numbness 1 1
Dysuria 1 1
Insufficient Information 1 1
Air Embolism 1 1
Fever 1 1
Low Blood Pressure/ Hypotension 1 1
Sepsis 1 1
Septic Shock 1 1
Sprain 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corporation II Nov-02-2018
2 Baxter Healthcare Corporation II Jan-11-2018
3 The Metrix Company II Oct-01-2019
4 The Metrix Company II Sep-29-2017
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