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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.
Product CodeKPE
Regulation Number 880.5025
Device Class 2


Premarket Reviews
ManufacturerDecision
ACTA MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
BEIJING L&Z MEDICAL TECHNOLOGY DEVELOPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
EPIC MEDICAL PTE LTD
  SUBSTANTIALLY EQUIVALENT 1
GILERO, LLC
  SUBSTANTIALLY EQUIVALENT 1
HAEMOTRONIC S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
HAEMOTRONIC, SPA
  SUBSTANTIALLY EQUIVALENT 1
HEALTH CARE TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
HOSPIRA, INC.
  SUBSTANTIALLY EQUIVALENT 1
INTERNATIONAL MEDICAL INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
VALMED S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
VALMED SRL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 574 574
2015 543 543
2016 527 527
2017 284 284
2018 142 157
2019 204 256
2020 147 147
2021 161 161
2022 112 112
2023 127 127
2024 31 31

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 956 994
Device Contamination with Chemical or Other Material 926 954
Leak/Splash 240 240
Contamination /Decontamination Problem 165 165
Hole In Material 98 98
Break 92 92
Disconnection 77 77
Particulates 35 35
Detachment of Device or Device Component 35 35
Failure to Disconnect 30 31
Crack 19 19
Cut In Material 18 18
Material Separation 16 16
Material Puncture/Hole 16 16
Misassembled 16 16
Connection Problem 15 15
Material Rupture 14 14
Contamination 13 13
Device Operates Differently Than Expected 12 12
Degraded 11 11
Product Quality Problem 10 10
Material Split, Cut or Torn 10 10
Suction Problem 9 9
Tear, Rip or Hole in Device Packaging 9 9
Improper or Incorrect Procedure or Method 8 8
Loose or Intermittent Connection 8 8
Mechanical Problem 8 8
Detachment Of Device Component 8 8
Microbial Contamination of Device 7 7
Device Dislodged or Dislocated 7 7
Environmental Particulates 7 7
Defective Component 6 6
Component Falling 6 6
Air Leak 6 6
Material Discolored 6 6
Difficult to Open or Close 6 6
Material Deformation 6 6
Material Integrity Problem 6 6
No Flow 5 5
Component Missing 5 5
Device Packaging Compromised 5 5
Defective Device 5 5
Contamination of Device Ingredient or Reagent 4 4
Device Disinfection Or Sterilization Issue 4 4
Failure to Infuse 4 4
Device Damaged Prior to Use 4 4
Decrease in Suction 4 4
Difficult to Remove 4 4
Improper Flow or Infusion 4 4
Torn Material 4 4
Component Misassembled 4 4
Manufacturing, Packaging or Shipping Problem 3 3
No Pressure 3 3
Fracture 3 3
Material Perforation 3 3
Unsealed Device Packaging 3 3
Separation Failure 3 3
Malposition of Device 2 2
Device Markings/Labelling Problem 2 2
Device Slipped 2 2
Entrapment of Device 2 2
Partial Blockage 2 2
Burst Container or Vessel 2 2
Device Difficult to Setup or Prepare 2 2
Decrease in Pressure 2 2
Kinked 2 2
Misconnection 2 2
Infusion or Flow Problem 2 2
Pressure Problem 2 2
Scratched Material 2 2
Sediment, Precipitate Or Deposit In Device Or Device Ingredient 2 2
Improper Chemical Reaction 2 2
Unexpected Color 2 2
Device Fell 2 2
Priming Problem 1 1
Separation Problem 1 1
Free or Unrestricted Flow 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Pumping Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Packaging Problem 1 1
Moisture Damage 1 1
Nonstandard Device 1 1
Delivered as Unsterile Product 1 1
Device Emits Odor 1 1
Failure to Prime 1 1
Precipitate in Device or Device Ingredient 1 1
Premature Activation 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Retraction Problem 1 1
Filling Problem 1 1
Material Fragmentation 1 1
Excess Flow or Over-Infusion 1 1
Labelling, Instructions for Use or Training Problem 1 1
Problem with Sterilization 1 1
Device Inoperable 1 1
Fitting Problem 1 1
Inadequacy of Device Shape and/or Size 1 1
Obstruction of Flow 1 1
Fail-Safe Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 1920 1974
No Clinical Signs, Symptoms or Conditions 409 409
No Known Impact Or Consequence To Patient 309 314
No Consequences Or Impact To Patient 144 152
Insufficient Information 33 33
No Information 24 24
No Code Available 4 4
Air Embolism 3 3
Death 2 2
Hypoxia 2 2
Injury 2 2
Numbness 1 1
Chemical Exposure 1 1
Weight Changes 1 1
Dysuria 1 1
Incontinence 1 1
Unspecified Infection 1 1
Nausea 1 1
Sepsis 1 1
Septic Shock 1 1
Sprain 1 1
Vomiting 1 1
Tingling 1 1
Diarrhea 1 1
Fever 1 1
Headache 1 1
Low Blood Pressure/ Hypotension 1 1
Exposure to Body Fluids 1 1
Complaint, Ill-Defined 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Baxa Corporation II Aug-02-2010
2 Baxa Corporation II Mar-09-2010
3 Baxter Healthcare Corp I Oct-31-2014
4 Baxter Healthcare Corp. II Apr-29-2010
5 Baxter Healthcare Corporation II Nov-02-2018
6 Baxter Healthcare Corporation II Jan-11-2018
7 Hospira Inc. II Sep-17-2012
8 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
9 Stradis Healthcare II Jan-11-2023
10 The Metrix Company II Oct-01-2019
11 The Metrix Company II Sep-29-2017
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