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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device introducer, syringe needle
Product CodeKZH
Regulation Number 880.6920
Device Class 2


Premarket Reviews
ManufacturerDecision
ELCAM MEDICAL A.C.A.L.
  SUBSTANTIALLY EQUIVALENT 1
EMED TECHNOLOGIES CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC MINIMED
  SUBSTANTIALLY EQUIVALENT 1
OWEN MUMFORD, LTD.
  SUBSTANTIALLY EQUIVALENT 1
SCANDINAVIAN HEALTH LIMITED
  SUBSTANTIALLY EQUIVALENT 2
YPSOMED AG
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 138 138
2015 99 99
2016 68 68
2017 88 88
2018 88 88
2019 95 95
2020 157 157
2021 87 87
2022 58 58
2023 35 35
2024 20 20

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended Ejection 326 326
Misfire 195 195
Break 47 47
Bent 42 42
Sticking 33 33
Device Operates Differently Than Expected 32 32
Defective Device 25 25
Failure to Deliver 22 22
Insufficient Information 18 18
Physical Resistance/Sticking 17 17
Mechanical Jam 16 16
Adverse Event Without Identified Device or Use Problem 13 13
Device Displays Incorrect Message 13 13
Defective Component 13 13
Therapeutic or Diagnostic Output Failure 12 12
Difficult to Insert 12 12
Fluid/Blood Leak 10 10
Leak/Splash 9 9
Material Twisted/Bent 9 9
Improper or Incorrect Procedure or Method 9 9
Output Problem 8 8
Component Missing 7 7
Mechanical Problem 6 6
Fitting Problem 5 5
Activation, Positioning or Separation Problem 5 5
Inaccurate Delivery 5 5
Device Inoperable 5 5
Kinked 5 5
Patient-Device Incompatibility 5 5
High Test Results 4 4
Use of Device Problem 4 4
Occlusion Within Device 4 4
Device Alarm System 4 4
Detachment Of Device Component 4 4
Ejection Problem 3 3
Failure To Adhere Or Bond 3 3
Difficult to Remove 3 3
Appropriate Term/Code Not Available 3 3
Dull, Blunt 3 3
Failure to Infuse 3 3
Device Slipped 3 3
Key or Button Unresponsive/not Working 2 2
Air Leak 2 2
Shipping Damage or Problem 2 2
Positioning Problem 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Crack 2 2
Improper Flow or Infusion 2 2
Failure to Eject 2 2
Loss of or Failure to Bond 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 341 341
No Known Impact Or Consequence To Patient 180 180
Hyperglycemia 146 146
No Clinical Signs, Symptoms or Conditions 140 140
Insufficient Information 36 36
Missed Dose 15 15
Hypoglycemia 15 15
Diabetic Ketoacidosis 11 11
Pain 10 10
Underdose 8 8
Needle Stick/Puncture 8 8
Aneurysm 7 7
No Information 6 6
Swelling 5 5
Reaction, Injection Site 4 4
Unspecified Infection 3 3
Bruise/Contusion 3 3
Loss of consciousness 3 3
No Code Available 3 3
Inflammation 3 3
Injury 3 3
Hemorrhage/Bleeding 2 2
Headache 2 2
Bacterial Infection 2 2
Anxiety 2 2
Dyspnea 2 2
No Patient Involvement 2 2
Erythema 2 2
Overdose 2 2
Scarring 2 2
Local Reaction 2 2
Itching Sensation 2 2
Nausea 2 2
Hypersensitivity/Allergic reaction 2 2
Alteration In Body Temperature 1 1
Fever 1 1
Irritation 1 1
Seroma 1 1
Weakness 1 1
Burning Sensation 1 1
Foreign Body In Patient 1 1
Blood Loss 1 1
Obstruction/Occlusion 1 1
Purulent Discharge 1 1
Abrasion 1 1
Chest Pain 1 1
Vomiting 1 1
Scar Tissue 1 1
Necrosis 1 1
Eye Injury 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Becton Dickinson & Company II Nov-07-2011
2 International Medsurg Connection, Inc. II Aug-04-2017
3 Owen Mumford USA, Inc. II Nov-01-2019
4 Owen Mumford USA, Inc. II Apr-02-2015
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