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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
Regulation Description Hypodermic single lumen needle.
Product CodeFMI
Regulation Number 880.5570
Device Class 2


Premarket Reviews
ManufacturerDecision
ACE MEDICAL INDUSTRY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ACTUATED MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ALTAVIZ, LLC
  SUBSTANTIALLY EQUIVALENT 2
ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
ANHUI TIANKANG MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
AZUR MEDICAL COMPANY, INC.
  SUBSTANTIALLY EQUIVALENT 1
BECTON, DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 4
BERPU MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
CARRTECH CORP
  SUBSTANTIALLY EQUIVALENT 1
CC BIOTECHNOLOGY CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
CHIRANA T. INJECTA
  SUBSTANTIALLY EQUIVALENT 1
CMT HEALTH PTE., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ECLIPSE MEDCORP, LLC
  SUBSTANTIALLY EQUIVALENT 1
EINSTEIN WORKS, LLC
  SUBSTANTIALLY EQUIVALENT 1
GANGAN MEDICAL TECHNOLOGY JIANGSU CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HANTECH MEDICAL DEVICE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
HH GLOBAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
HTL STREFA SA
  SUBSTANTIALLY EQUIVALENT 1
HTL-STREFA S.A
  SUBSTANTIALLY EQUIVALENT 2
JIANGSU CAINA MEDICAL CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
NINGBO MEDSUN MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
NIPRO MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
NOVO NORDISK, INC.
  SUBSTANTIALLY EQUIVALENT 3
OCUJECT, LLC
  SUBSTANTIALLY EQUIVALENT 3
OWEN MUMFORD, LTD.
  SUBSTANTIALLY EQUIVALENT 1
PIKDARE SPA
  SUBSTANTIALLY EQUIVALENT 2
POONGLIM PHARMATECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
PROMAMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
PROMISEMED HANGZHOU MEDITECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 10
SANDSTONE MEDICAL (SUZHOU), INC.
  SUBSTANTIALLY EQUIVALENT 3
SHANGHAI KINDLY ENTERPRISE DEVELOPMENT GROUP CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHINA CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SHINA MED CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SICHUAN PRIUS BIOTECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SMITHS MEDICAL ASD, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPECTRUM VASCULAR
  SUBSTANTIALLY EQUIVALENT 1
TELEFLEX MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
TERUMO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TERUMO EUROPE N.V.
  SUBSTANTIALLY EQUIVALENT 4
TIANJIN HUAHONG TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
TSK LABORATORY, JAPAN
  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 1
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 2
ZIEN MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 4245 4265
2021 4532 4581
2022 4885 4940
2023 4986 5019
2024 4053 4059
2025 2464 2464
2026 540 540

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Deliver 5665 5671
Complete Blockage 3091 3091
Break 2954 2990
Leak/Splash 2133 2137
Device Contamination with Chemical or Other Material 1304 1306
Defective Device 918 932
Misconnection 810 810
Fluid/Blood Leak 754 765
Detachment of Device or Device Component 671 701
Device Markings/Labelling Problem 609 613
Defective Component 572 588
Difficult or Delayed Activation 565 565
Product Quality Problem 378 383
Material Protrusion/Extrusion 354 355
Contamination 349 349
Packaging Problem 342 346
Material Twisted/Bent 340 370
Component Missing 286 293
Material Separation 249 256
No Flow 241 241
Obstruction of Flow 230 233
Failure to Cut 221 223
Separation Problem 218 219
Adverse Event Without Identified Device or Use Problem 205 207
Delivered as Unsterile Product 197 197
Physical Resistance/Sticking 181 185
Fail-Safe Problem 167 168
Partial Blockage 164 164
Crack 153 154
Difficult to Remove 143 143
Material Deformation 143 143
Off-Label Use 140 140
Contamination /Decontamination Problem 132 132
Dull, Blunt 126 153
Material Puncture/Hole 126 128
Failure to Prime 122 123
Malposition of Device 122 122
Activation Problem 121 121
Connection Problem 107 108
Power Problem 106 106
Loose or Intermittent Connection 101 106
Retraction Problem 96 97
Fail-Safe Did Not Operate 96 123
Missing Information 84 84
Insufficient Information 72 72
Mechanical Problem 72 79
Disconnection 68 72
Material Fragmentation 63 63
Volume Accuracy Problem 62 62
Premature Activation 61 61

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 18440 18507
No Consequences Or Impact To Patient 2006 2006
No Known Impact Or Consequence To Patient 1432 1438
Needle Stick/Puncture 1134 1165
Insufficient Information 933 957
No Patient Involvement 606 606
Foreign Body In Patient 455 463
Pain 264 270
Hyperglycemia 261 261
Exposure to Body Fluids 92 92
Device Embedded In Tissue or Plaque 89 91
Hemorrhage/Bleeding 66 66
No Information 61 61
Injection Site Reaction 54 54
Bruise/Contusion 50 51
Discomfort 43 44
Skin Inflammation/ Irritation 43 43
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 41 56
Swelling/ Edema 38 38
Hypoglycemia 29 31
Injury 23 24
Underdose 23 23
Hypersensitivity/Allergic reaction 18 18
Chemical Exposure 17 17
Anxiety 17 17
Laceration(s) 16 20
Erythema 14 15
Unspecified Tissue Injury 14 14
Endophthalmitis 14 14
Skin Tears 14 14
Bacterial Infection 13 13
Easy Bruising 13 13
No Code Available 12 12
Hematoma 12 12
Itching Sensation 11 12
Visual Impairment 11 12
Dizziness 10 10
Diabetic Ketoacidosis 10 11
Rash 10 11
Irritation 10 10
Subcutaneous Nodule 10 10
Fever 9 9
Hypopyon 8 8
Abscess 8 8
Inflammation 7 7
Skin Infection 7 7
Unspecified Infection 6 6
Blood Loss 6 6
Immunodeficiency 5 5
Extravasation 5 5

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 C.A. Greiner & Sohne Gesellschaftmbh II Aug-28-2020
8 Cardinal Health 200, LLC II Mar-15-2021
9 Cardinal Health 200, LLC II Nov-05-2020
10 Cardinal Health 200, LLC II Mar-09-2020
11 Cardinal Health Inc. II Jun-23-2021
12 Embecta Corp. II Jul-23-2024
13 Greiner Bio-One GmbH II Jan-03-2025
14 Owen Mumford USA, Inc. II Jul-15-2021
15 Retractable Technologies, Inc. II Mar-14-2024
16 Waismed Ltd. II Jul-17-2025
17 Zhejiang Kindly Medical Devices Co., Ltd. II Nov-05-2021
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