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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
Device needle, hypodermic, single lumen
Product CodeFMI
Regulation Number 880.5570
Device Class 2


Premarket Reviews
ManufacturerDecision
ACTUATED MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
ALTAVIZ, LLC
  SUBSTANTIALLY EQUIVALENT 2
ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
ANHUI TIANKANG MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ANHUI TIANKANG MEDICAL TECHNOLOGY CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
AZUR MEDICAL COMPANY INC.
  SUBSTANTIALLY EQUIVALENT 1
BARD ACCESS SYSTEMS, INC(BAS)[WHOLLY-OWNED SUBSIDIARY OF BD]
  SUBSTANTIALLY EQUIVALENT 1
BECTON DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 1
BECTON, DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 1
BECTON, DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 3
BERPU MEDICAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
BERPU MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
CC BIOTECHNOLOGY CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
CHIRANA T. INJECTA
  SUBSTANTIALLY EQUIVALENT 1
ECLIPSE MEDCORP, LLC
  SUBSTANTIALLY EQUIVALENT 1
EINSTEIN WORKS LLC
  SUBSTANTIALLY EQUIVALENT 1
EINSTEIN WORKS, L.L.C
  SUBSTANTIALLY EQUIVALENT 1
EINSTEIN WORKS, L.L.C.
  SUBSTANTIALLY EQUIVALENT 1
GANGAN MEDICAL TECHNOLOGY JIANGSU CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HANTECH MEDICAL DEVICE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
HTL STREFA SA
  SUBSTANTIALLY EQUIVALENT 1
HTL-STREFA S.A
  SUBSTANTIALLY EQUIVALENT 1
HTL-STREFA S.A.
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU CAINA MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
NINGBO MEDSUN MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
NIPRO MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
NOVO NORDISK INC.
  SUBSTANTIALLY EQUIVALENT 3
OCUJECT, LLC
  SUBSTANTIALLY EQUIVALENT 3
OCUJET, LLC
  SUBSTANTIALLY EQUIVALENT 1
OWEN MUMFORD LTD
  SUBSTANTIALLY EQUIVALENT 1
PIKDARE S.P.A
  SUBSTANTIALLY EQUIVALENT 1
PIKDARE SPA
  SUBSTANTIALLY EQUIVALENT 1
PIPER ACCESS, LLC
  SUBSTANTIALLY EQUIVALENT 1
POONGLIM PHARMATECH INC.
  SUBSTANTIALLY EQUIVALENT 1
PROMAMEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
PROMISEMED HANGZHOU MEDITECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 8
SAM® MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SANDSTONE MEDICAL (SUZHOU) INC.
  SUBSTANTIALLY EQUIVALENT 2
SHANGHAI KINDLY ENTERPRISE DEVELOPMENT GROUP CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
SHINA CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SICHUAN PRIUS BIOTECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SMITHS MEDICAL ASD, INC.
  SUBSTANTIALLY EQUIVALENT 1
TELEFLEX MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
TERUMO EUROPE N.V.
  SUBSTANTIALLY EQUIVALENT 2
TIANJIN HUAHONG TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
U&U MEDICAL TECHNOLOGY CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
U-NEEDLE B.V.
  SUBSTANTIALLY EQUIVALENT 1
ULTIMED INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
VACUTEST KIMA SRL
  SUBSTANTIALLY EQUIVALENT 1
W. L. MED CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
WAISMED LTD
  SUBSTANTIALLY EQUIVALENT 2
WEPON MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
ZHEJIANG KANGKANG MEDICAL-DEVICES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
ZHEJIANG KINDLY MEDICAL DEVICE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZHEJIANG KINDLY MEDICAL DEVICES CO. LTD
  SUBSTANTIALLY EQUIVALENT 1
ZHEJIANG KINDLY MEDICAL DEVICES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 4894 4894
2020 4243 4243
2021 4528 4528
2022 4885 4886
2023 4991 4991
2024 1333 1333

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Deliver 5930 5930
Complete Blockage 2920 2920
Break 2784 2784
Leak/Splash 2288 2288
Device Contamination with Chemical or Other Material 1455 1455
Misconnection 959 959
Defective Device 871 871
Device Markings/Labelling Problem 699 699
Difficult or Delayed Activation 584 584
Fluid/Blood Leak 578 578
Detachment of Device or Device Component 526 527
Defective Component 431 431
Material Protrusion/Extrusion 416 416
Packaging Problem 374 374
Product Quality Problem 364 364
Material Twisted/Bent 315 315
Component Missing 303 303
Failure to Cut 268 268
Obstruction of Flow 229 229
Delivered as Unsterile Product 224 224
Contamination 220 220
Separation Problem 215 215
Adverse Event Without Identified Device or Use Problem 207 207
Physical Resistance/Sticking 178 178
Material Separation 178 178
No Flow 175 175
Crack 165 165
Power Problem 161 161
Material Deformation 147 147
Partial Blockage 137 137
Fail-Safe Problem 130 130
Failure to Prime 124 124
Device Damaged Prior to Use 113 113
Material Puncture/Hole 111 111
Dull, Blunt 109 109
Fail-Safe Did Not Operate 96 96
Retraction Problem 93 93
Loose or Intermittent Connection 90 90
Volume Accuracy Problem 90 90
Contamination /Decontamination Problem 88 88
Missing Information 83 83
Activation Problem 78 78
Infusion or Flow Problem 76 76
Difficult to Remove 68 68
Material Fragmentation 65 65
Incomplete or Inadequate Connection 65 65
Device Misassembled During Manufacturing /Shipping 62 62
Mechanical Problem 57 57
Separation Failure 53 53
Use of Device Problem 53 53
Fitting Problem 50 50
Difficult to Open or Close 48 48
Complete Loss of Power 48 48
Protective Measures Problem 47 47
Disconnection 47 47
Mechanical Jam 46 46
Manufacturing, Packaging or Shipping Problem 42 42
Device Dislodged or Dislocated 42 42
Improper or Incorrect Procedure or Method 40 40
Insufficient Information 39 39
Tear, Rip or Hole in Device Packaging 35 35
Connection Problem 35 35
Unsealed Device Packaging 35 35
Nonstandard Device 34 34
Activation Failure 33 33
Difficult to Insert 32 32
Device Difficult to Setup or Prepare 32 32
Patient-Device Incompatibility 32 32
Insufficient Flow or Under Infusion 30 30
Material Integrity Problem 30 30
Device Contaminated During Manufacture or Shipping 29 29
Improper Flow or Infusion 29 29
Illegible Information 29 29
Inaccurate Information 26 26
Malposition of Device 25 25
Loss of or Failure to Bond 24 24
Appropriate Term/Code Not Available 24 24
Premature Separation 22 22
Incomplete or Missing Packaging 21 21
Failure to Infuse 21 21
Material Perforation 21 21
Contamination of Device Ingredient or Reagent 20 20
Positioning Failure 20 20
Entrapment of Device 20 20
Failure to Disconnect 18 18
Shielding Failure 18 18
Fungus in Device Environment 18 18
Air/Gas in Device 18 18
Difficult or Delayed Positioning 17 17
Incorrect, Inadequate or Imprecise Result or Readings 16 16
Inaccurate Delivery 16 16
Device Slipped 15 15
Failure to Align 15 15
Fracture 15 15
Device Handling Problem 15 15
Output Problem 15 15
Inadequacy of Device Shape and/or Size 14 14
Activation, Positioning or Separation Problem 13 13
Off-Label Use 13 13
No Apparent Adverse Event 13 13

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 13749 13750
No Known Impact Or Consequence To Patient 5124 5124
No Consequences Or Impact To Patient 2237 2237
Needle Stick/Puncture 941 941
No Patient Involvement 759 759
Insufficient Information 637 637
Foreign Body In Patient 339 339
No Information 334 334
Pain 276 276
Hyperglycemia 272 272
Exposure to Body Fluids 115 115
Device Embedded In Tissue or Plaque 106 106
Bruise/Contusion 67 67
Underdose 65 65
Hemorrhage/Bleeding 55 55
No Code Available 46 46
Skin Inflammation/ Irritation 37 37
Discomfort 35 35
Hypoglycemia 32 32
Injury 31 31
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 31 31
Injection Site Reaction 28 28
Swelling/ Edema 26 26
Hypersensitivity/Allergic reaction 23 23
Laceration(s) 20 20
Anxiety 17 17
Chemical Exposure 16 16
Missed Dose 15 15
Erythema 15 15
Bacterial Infection 13 13
Swelling 13 13
Hematoma 12 12
Blood Loss 12 12
Dizziness 12 12
Diabetic Ketoacidosis 12 12
Skin Tears 11 11
Easy Bruising 11 11
Itching Sensation 11 11
Nerve Damage 10 10
Irritation 10 10
Unspecified Infection 10 10
Visual Impairment 10 10
Endophthalmitis 10 10
Unspecified Tissue Injury 10 10
Subcutaneous Nodule 10 10
Reaction 9 9
Inflammation 9 9
Overdose 9 9
Hypopyon 8 8
Rash 8 8
Fever 8 8
Abscess 7 7
Burning Sensation 7 7
Skin Irritation 7 7
Missing Value Reason 7 7
Nausea 6 6
Headache 5 5
Patient Problem/Medical Problem 5 5
Skin Infection 5 5
Reaction, Injection Site 5 5
Distress 4 4
Vessel Or Plaque, Device Embedded In 4 4
Death 4 4
Scarring 4 4
Sepsis 4 4
Local Reaction 3 3
Neuropathy 3 3
Miscarriage 3 3
Muscle Weakness 3 3
Cardiac Arrest 3 3
High Blood Pressure/ Hypertension 3 3
Fall 3 3
Extravasation 3 3
Inadequate Pain Relief 3 3
Premature Labor 3 3
Respiratory Arrest 3 3
Syncope/Fainting 3 3
Test Result 2 2
Blister 2 2
Skin Inflammation 2 2
Post Operative Wound Infection 2 2
Coma 2 2
Weight Changes 2 2
Abdominal Cramps 2 2
Confusion/ Disorientation 2 2
Electrolyte Imbalance 2 2
Fainting 2 2
Fatigue 2 2
Hepatitis 2 2
Foreign Body Sensation in Eye 2 2
Cellulitis 2 2
Air Embolism 2 2
Abdominal Pain 2 2
Abrasion 2 2
Emotional Changes 2 2
Purulent Discharge 2 2
Vomiting 2 2
Vertigo 2 2
Blurred Vision 2 2
Tissue Damage 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Apellis Pharmaceuticals, Inc. II Sep-29-2023
2 Bard Access Systems, Inc. I Jul-22-2022
3 Bard Peripheral Vascular Inc II Oct-01-2021
4 Becton Dickinson & Company II Dec-15-2020
5 Becton Dickinson & Company II Nov-27-2020
6 Becton Dickinson & Company II Aug-27-2020
7 Becton Dickinson & Company II Oct-31-2019
8 Becton Dickinson & Company II Oct-24-2019
9 Becton Dickinson & Company II Jul-22-2019
10 C.A. Greiner & Sohne Gesellschaftmbh II Aug-28-2020
11 Cardinal Health 200, LLC II Mar-15-2021
12 Cardinal Health 200, LLC II Nov-05-2020
13 Cardinal Health 200, LLC II Mar-09-2020
14 Cardinal Health 200, LLC II Jul-23-2019
15 Cardinal Health Inc. II Jun-23-2021
16 Guangzhou Improve Medical Instruments Co., Ltd. II Apr-24-2019
17 Owen Mumford USA, Inc. II Jul-15-2021
18 Retractable Technologies, Inc. II Mar-14-2024
19 Smiths Medical ASD Inc. II Jun-04-2019
20 Teleflex Medical II Dec-16-2019
21 Terumo Medical Corporation II Jul-22-2019
22 Zhejiang Kindly Medical Devices Co., Ltd. II Nov-05-2021
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