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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
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 4
EINSTEIN WORKS, LLC
  SUBSTANTIALLY EQUIVALENT 1
HANGZHOU QIANTANG LONGYUE BIOTECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HANTECH MEDICAL DEVICE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
HH GLOBAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 2
HTL STREFA SA
  SUBSTANTIALLY EQUIVALENT 1
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 2
OCUJECT, LLC
  SUBSTANTIALLY EQUIVALENT 3
OWEN MUMFORD, LTD.
  SUBSTANTIALLY EQUIVALENT 1
PIKDARE SPA
  SUBSTANTIALLY EQUIVALENT 2
PROMAMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
PROMISEMED HANGZHOU MEDITECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 9
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
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
2021 4532 4581
2022 4885 4940
2023 4986 5019
2024 4053 4059
2025 2465 2465
2026 925 925

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Deliver 4321 4323
Complete Blockage 2880 2880
Break 2429 2434
Leak/Splash 1553 1553
Device Contamination with Chemical or Other Material 1037 1038
Fluid/Blood Leak 649 649
Defective Device 634 634
Misconnection 597 597
Defective Component 556 560
Detachment of Device or Device Component 522 525
Difficult or Delayed Activation 426 426
Device Markings/Labelling Problem 411 411
Contamination 334 334
Product Quality Problem 286 286
Material Protrusion/Extrusion 255 256
Component Missing 236 236
No Flow 235 235
Packaging Problem 222 222
Obstruction of Flow 221 221
Material Separation 214 217
Separation Problem 211 211
Material Twisted/Bent 198 198
Adverse Event Without Identified Device or Use Problem 161 161
Partial Blockage 161 161
Physical Resistance/Sticking 158 158
Failure to Cut 148 150
Off-Label Use 139 139
Fail-Safe Problem 137 137
Delivered as Unsterile Product 135 135
Difficult to Remove 131 131
Material Deformation 128 128
Contamination /Decontamination Problem 125 125
Malposition of Device 123 123
Activation Problem 122 122
Material Puncture/Hole 121 121
Crack 120 120
Failure to Prime 119 120
Connection Problem 104 104
Dull, Blunt 84 84
Missing Information 83 83
Loose or Intermittent Connection 81 81
Retraction Problem 66 66
Premature Activation 63 63
Insufficient Device Problem Information 62 62
Incomplete or Inadequate Connection 56 56
Mechanical Problem 53 53
Complete Loss of Power 51 51
Volume Accuracy Problem 51 51
Power Problem 51 51
Material Integrity Problem 51 51

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 18500 18558
Needle Stick/Puncture 996 1026
Insufficient Information 902 924
No Consequences Or Impact To Patient 485 485
Foreign Body In Patient 412 420
Pain 238 244
Hyperglycemia 180 180
Injection Site Reaction 76 76
Exposure to Body Fluids 68 68
Device Embedded In Tissue or Plaque 64 66
Hemorrhage/Blood Loss/Bleeding 63 63
Swelling/ Edema 43 43
Discomfort 42 43
Skin Inflammation/ Irritation 42 42
No Patient Involvement 40 40
Bruise/Contusion 37 38
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 36 51
Hypoglycemia 22 24
Abscess 17 17
Hypersensitivity/Allergic reaction 16 16
Anxiety 15 15
Laceration(s) 15 19
Chemical Exposure 14 14
Unspecified Tissue Injury 13 13
Bacterial Infection 13 13
Easy Bruising 13 13
Skin Tears 13 13
Erythema 12 12
Subcutaneous Nodule 10 10
Hematoma 10 10
Fever 9 9
Cellulitis 9 9
Itching Sensation 9 9
Dizziness 9 9
Elevated ketones/Diabetic Ketoacidosis 9 10
Unintended Loss of Vascular Access 8 8
Irritation 8 8
Rash 8 8
Skin Infection 8 8
Emotional Changes 7 7
Necrosis 6 6
Endophthalmitis 6 6
Immunodeficiency 5 5
Inflammation 5 5
No Information 5 5
Cardiac Arrest 5 5
Intraoperative Cardiac Valve Injury 5 5
Extravasation 5 5
Sepsis 4 4
Underdose 3 3

Recalls
Manufacturer Recall Class Date Posted
1 Apellis Pharmaceuticals, Inc. II Sep-29-2023
2 Bard Access Systems, Inc. I Aug-14-2026
3 Bard Access Systems, Inc. I Jul-22-2022
4 Bard Peripheral Vascular Inc II Oct-01-2021
5 Cardinal Health 200, LLC II Mar-15-2021
6 Cardinal Health Inc. II Jun-23-2021
7 Embecta Corp. II Jul-23-2024
8 Greiner Bio-One GmbH II Jan-03-2025
9 Owen Mumford USA, Inc. II Jul-15-2021
10 Retractable Technologies, Inc. II Mar-14-2024
11 Waismed Ltd. II Jul-17-2025
12 Zhejiang Kindly Medical Devices Co., Ltd. II Nov-05-2021
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