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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 94 94
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 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended Ejection 325 325
Misfire 191 191
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
Device Displays Incorrect Message 13 13
Defective Component 13 13
Adverse Event Without Identified Device or Use Problem 13 13
Therapeutic or Diagnostic Output Failure 12 12
Difficult to Insert 12 12
Fluid/Blood Leak 10 10
Leak/Splash 9 9
Improper or Incorrect Procedure or Method 9 9
Material Twisted/Bent 9 9
Output Problem 8 8
Component Missing 7 7
Mechanical Problem 6 6
Kinked 5 5
Device Inoperable 5 5
Inaccurate Delivery 5 5
Activation, Positioning or Separation Problem 5 5
Patient-Device Incompatibility 5 5
Fitting Problem 5 5
Use of Device Problem 4 4
High Test Results 4 4
Occlusion Within Device 4 4
Detachment Of Device Component 4 4
Device Alarm System 4 4
Failure To Adhere Or Bond 3 3
Difficult to Remove 3 3
Device Slipped 3 3
Failure to Infuse 3 3
Dull, Blunt 3 3
Appropriate Term/Code Not Available 3 3
Ejection Problem 3 3
Failure to Eject 2 2
Noise, Audible 2 2
Key or Button Unresponsive/not Working 2 2
Packaging Problem 2 2
Positioning Problem 2 2
Naturally Worn 2 2
Insufficient Flow or Under Infusion 2 2
Failure to Fire 2 2
Connection Problem 2 2
Detachment of Device or Device Component 2 2
Improper Flow or Infusion 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Retraction Problem 2 2
Air Leak 2 2
Shipping Damage or Problem 2 2
Loss of or Failure to Bond 2 2
Component Falling 2 2
Crack 2 2
Difficult or Delayed Positioning 1 1
Disconnection 1 1
Entrapment of Device 1 1
Use of Incorrect Control/Treatment Settings 1 1
Excess Flow or Over-Infusion 1 1
Burst Container or Vessel 1 1
Device Reprocessing Problem 1 1
Complete Blockage 1 1
Material Separation 1 1
Unstable 1 1
Unexpected Therapeutic Results 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Device Difficult to Setup or Prepare 1 1
Failure to Prime 1 1
Mechanics Altered 1 1
Moisture or Humidity Problem 1 1
Inadequate User Interface 1 1
Calibration Problem 1 1
Device Operational Issue 1 1
Device Packaging Compromised 1 1
Device-Device Incompatibility 1 1
Separation Failure 1 1
Structural Problem 1 1
Device Contamination with Body Fluid 1 1
Obstruction of Flow 1 1
No Flow 1 1
No Apparent Adverse Event 1 1
Protective Measures Problem 1 1
Activation Problem 1 1
Firing Problem 1 1
Device Handling Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 336 336
No Known Impact Or Consequence To Patient 180 180
Hyperglycemia 146 146
No Clinical Signs, Symptoms or Conditions 128 128
Insufficient Information 34 34
Missed Dose 15 15
Hypoglycemia 15 15
Diabetic Ketoacidosis 11 11
Pain 10 10
Underdose 8 8
Needle Stick/Puncture 7 7
No Information 6 6
Swelling 5 5
Reaction, Injection Site 4 4
No Code Available 3 3
Loss of consciousness 3 3
Injury 3 3
Unspecified Infection 3 3
Inflammation 3 3
Bruise/Contusion 3 3
Aneurysm 2 2
Bacterial Infection 2 2
Hypersensitivity/Allergic reaction 2 2
Headache 2 2
Hemorrhage/Bleeding 2 2
Dyspnea 2 2
Erythema 2 2
Local Reaction 2 2
Itching Sensation 2 2
Nausea 2 2
Scarring 2 2
Overdose 2 2
Anxiety 2 2
No Patient Involvement 2 2
Alteration In Body Temperature 1 1
Foreign Body In Patient 1 1
Blood Loss 1 1
Urinary Frequency 1 1
Arthralgia 1 1
Obstruction/Occlusion 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Sepsis 1 1
Seroma 1 1
Skin Irritation 1 1
Tinnitus 1 1
Vomiting 1 1
Weakness 1 1
Burning Sensation 1 1
Necrosis 1 1
Scar Tissue 1 1
Irritation 1 1
Eye Injury 1 1
Fainting 1 1
Fever 1 1
High Blood Pressure/ Hypertension 1 1
Abdominal Pain 1 1
Abrasion 1 1
Cataract 1 1
Chest Pain 1 1
Purulent Discharge 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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