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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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 1019 1019

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Deliver 5813 5813
Complete Blockage 2893 2893
Break 2756 2756
Leak/Splash 2270 2270
Device Contamination with Chemical or Other Material 1426 1426
Misconnection 945 945
Defective Device 864 864
Device Markings/Labelling Problem 693 693
Fluid/Blood Leak 577 577
Difficult or Delayed Activation 565 565
Detachment of Device or Device Component 522 523
Defective Component 425 425
Material Protrusion/Extrusion 409 409
Packaging Problem 367 367
Product Quality Problem 357 357
Material Twisted/Bent 313 313
Component Missing 303 303
Failure to Cut 263 263
Obstruction of Flow 229 229
Delivered as Unsterile Product 224 224
Contamination 217 217
Separation Problem 214 214
Adverse Event Without Identified Device or Use Problem 207 207
Material Separation 177 177
Physical Resistance/Sticking 175 175
No Flow 171 171
Crack 164 164
Power Problem 161 161
Material Deformation 147 147
Partial Blockage 136 136
Fail-Safe Problem 128 128
Failure to Prime 124 124
Device Damaged Prior to Use 112 112
Material Puncture/Hole 109 109
Dull, Blunt 106 106
Fail-Safe Did Not Operate 95 95
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 75 75
Difficult to Remove 68 68
Incomplete or Inadequate Connection 65 65
Material Fragmentation 64 64
Device Misassembled During Manufacturing /Shipping 61 61
Mechanical Problem 57 57
Separation Failure 52 52
Fitting Problem 50 50
Use of Device Problem 49 49
Difficult to Open or Close 48 48
Complete Loss of Power 48 48
Protective Measures Problem 47 47
Disconnection 46 46
Mechanical Jam 44 44
Device Dislodged or Dislocated 42 42
Manufacturing, Packaging or Shipping Problem 41 41
Improper or Incorrect Procedure or Method 37 37
Tear, Rip or Hole in Device Packaging 35 35
Unsealed Device Packaging 35 35
Nonstandard Device 34 34
Connection Problem 34 34
Activation Failure 33 33
Patient-Device Incompatibility 32 32
Difficult to Insert 32 32
Device Difficult to Setup or Prepare 32 32
Material Integrity Problem 30 30
Insufficient Information 30 30
Device Contaminated During Manufacture or Shipping 29 29
Improper Flow or Infusion 29 29
Illegible Information 29 29
Insufficient Flow or Under Infusion 29 29
Inaccurate Information 26 26
Appropriate Term/Code Not Available 23 23
Premature Separation 22 22
Malposition of Device 22 22
Loss of or Failure to Bond 22 22
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
Incomplete or Missing Packaging 19 19
Fungus in Device Environment 18 18
Shielding Failure 18 18
Failure to Disconnect 18 18
Air/Gas in Device 18 18
Difficult or Delayed Positioning 17 17
Incorrect, Inadequate or Imprecise Result or Readings 16 16
Fracture 15 15
Device Slipped 15 15
Inaccurate Delivery 15 15
Device Handling Problem 15 15
Output Problem 15 15
Inadequacy of Device Shape and/or Size 14 14
Failure to Align 14 14
Activation, Positioning or Separation Problem 13 13
No Apparent Adverse Event 13 13
Therapeutic or Diagnostic Output Failure 13 13

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 13477 13478
No Known Impact Or Consequence To Patient 5124 5124
No Consequences Or Impact To Patient 2237 2237
Needle Stick/Puncture 922 922
No Patient Involvement 759 759
Insufficient Information 623 623
Foreign Body In Patient 338 338
No Information 334 334
Hyperglycemia 271 271
Pain 271 271
Exposure to Body Fluids 114 114
Device Embedded In Tissue or Plaque 105 105
Bruise/Contusion 67 67
Underdose 65 65
Hemorrhage/Bleeding 53 53
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 30 30
Swelling/ Edema 25 25
Injection Site Reaction 25 25
Hypersensitivity/Allergic reaction 23 23
Laceration(s) 19 19
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
Diabetic Ketoacidosis 12 12
Dizziness 11 11
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
Patient Problem/Medical Problem 5 5
Skin Infection 5 5
Reaction, Injection Site 5 5
Nausea 5 5
Headache 5 5
Vessel Or Plaque, Device Embedded In 4 4
Death 4 4
Scarring 4 4
Sepsis 4 4
Distress 4 4
Inadequate Pain Relief 3 3
Premature Labor 3 3
Respiratory Arrest 3 3
Syncope/Fainting 3 3
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
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
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
Anaphylactoid 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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