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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 2
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 396 396

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Deliver 5664 5670
Complete Blockage 3087 3087
Break 2921 2957
Leak/Splash 2122 2126
Device Contamination with Chemical or Other Material 1303 1305
Defective Device 914 928
Misconnection 810 810
Fluid/Blood Leak 741 752
Detachment of Device or Device Component 658 688
Device Markings/Labelling Problem 609 613
Defective Component 572 588
Difficult or Delayed Activation 562 562
Product Quality Problem 374 379
Material Protrusion/Extrusion 353 354
Packaging Problem 340 344
Contamination 339 339
Material Twisted/Bent 335 365
Component Missing 286 293
Material Separation 247 254
No Flow 236 236
Obstruction of Flow 227 230
Failure to Cut 221 223
Separation Problem 218 219
Adverse Event Without Identified Device or Use Problem 205 207
Delivered as Unsterile Product 196 196
Physical Resistance/Sticking 181 185
Fail-Safe Problem 166 167
Partial Blockage 164 164
Crack 149 150
Material Deformation 142 142
Off-Label Use 140 140
Difficult to Remove 134 134
Contamination /Decontamination Problem 129 129
Dull, Blunt 126 153
Failure to Prime 122 123
Malposition of Device 121 121
Material Puncture/Hole 121 123
Activation Problem 120 120
Power Problem 106 106
Connection Problem 102 103
Loose or Intermittent Connection 101 106
Retraction Problem 96 97
Fail-Safe Did Not Operate 93 120
Missing Information 84 84
Insufficient Information 72 72
Mechanical Problem 69 76
Disconnection 68 72
Volume Accuracy Problem 62 62
Material Fragmentation 62 62
Incomplete or Inadequate Connection 61 61

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 18334 18401
No Consequences Or Impact To Patient 2006 2006
No Known Impact Or Consequence To Patient 1432 1438
Needle Stick/Puncture 1127 1158
Insufficient Information 926 950
No Patient Involvement 606 606
Foreign Body In Patient 441 449
Pain 263 269
Hyperglycemia 259 259
Exposure to Body Fluids 92 92
Device Embedded In Tissue or Plaque 88 90
Hemorrhage/Bleeding 65 65
No Information 61 61
Injection Site Reaction 52 52
Bruise/Contusion 50 51
Skin Inflammation/ Irritation 43 43
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 41 56
Discomfort 41 42
Swelling/ Edema 38 38
Hypoglycemia 29 31
Injury 23 24
Underdose 23 23
Hypersensitivity/Allergic reaction 18 18
Chemical Exposure 17 17
Laceration(s) 16 20
Anxiety 15 15
Erythema 14 15
Skin Tears 14 14
Unspecified Tissue Injury 14 14
Endophthalmitis 14 14
Bacterial Infection 13 13
Easy Bruising 13 13
No Code Available 12 12
Hematoma 12 12
Visual Impairment 11 12
Itching Sensation 11 12
Diabetic Ketoacidosis 10 11
Dizziness 10 10
Irritation 10 10
Rash 10 11
Subcutaneous Nodule 10 10
Fever 9 9
Abscess 8 8
Hypopyon 8 8
Inflammation 7 7
Skin Infection 7 7
Unspecified Infection 6 6
Blood Loss 6 6
Immunodeficiency 5 5
Cardiac Arrest 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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