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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 2
AZUR MEDICAL COMPANY, INC.
  SUBSTANTIALLY EQUIVALENT 1
BECTON, DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 5
BERPU MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
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 3
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
OCUJET, LLC
  SUBSTANTIALLY EQUIVALENT 1
OWEN MUMFORD, LTD.
  SUBSTANTIALLY EQUIVALENT 1
PIKDARE SPA
  SUBSTANTIALLY EQUIVALENT 2
PIPER ACCESS, LLC
  SUBSTANTIALLY EQUIVALENT 1
POONGLIM PHARMATECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
PROMAMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
PROMISEMED HANGZHOU MEDITECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 10
SAM® MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
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 5
TIANJIN HUAHONG TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
TSK LABORATORY, JAPAN
  SUBSTANTIALLY EQUIVALENT 1
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 2
ZIEN MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 4896 4921
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 6860 6866
Break 3407 3444
Complete Blockage 3316 3316
Leak/Splash 2791 2796
Device Contamination with Chemical or Other Material 1660 1662
Misconnection 1123 1123
Defective Device 1066 1099
Fluid/Blood Leak 840 851
Device Markings/Labelling Problem 784 788
Difficult or Delayed Activation 755 755
Detachment of Device or Device Component 748 779
Defective Component 578 594
Material Protrusion/Extrusion 470 471
Product Quality Problem 460 465
Packaging Problem 433 437
Material Twisted/Bent 423 455
Component Missing 346 353
Contamination 341 341
Failure to Cut 280 282
Delivered as Unsterile Product 259 259
Obstruction of Flow 256 259
Material Separation 255 262
Adverse Event Without Identified Device or Use Problem 244 246
No Flow 240 240
Separation Problem 235 236
Physical Resistance/Sticking 203 207
Crack 192 193
Contamination /Decontamination Problem 189 189
Fail-Safe Problem 184 185
Partial Blockage 165 165
Dull, Blunt 163 190
Material Deformation 162 162
Power Problem 162 162
Off-Label Use 142 142
Difficult to Remove 141 141
Material Puncture/Hole 138 140
Activation Problem 136 136
Failure to Prime 124 125
Malposition of Device 122 122
Device Damaged Prior to Use 116 116
Loose or Intermittent Connection 114 119
Connection Problem 111 112
Fail-Safe Did Not Operate 111 138
Retraction Problem 103 104
Volume Accuracy Problem 93 93
Mechanical Problem 90 97
Missing Information 84 84
Infusion or Flow Problem 82 82
Insufficient Information 82 82
Material Fragmentation 77 77

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 18336 18403
No Known Impact Or Consequence To Patient 5124 5153
No Consequences Or Impact To Patient 2237 2237
Needle Stick/Puncture 1304 1335
Insufficient Information 926 950
No Patient Involvement 759 759
Foreign Body In Patient 499 508
Pain 339 346
No Information 334 334
Hyperglycemia 299 299
Device Embedded In Tissue or Plaque 123 125
Exposure to Body Fluids 121 121
Hemorrhage/Bleeding 82 82
Bruise/Contusion 75 76
Underdose 65 65
Injection Site Reaction 52 52
Discomfort 52 53
No Code Available 47 47
Skin Inflammation/ Irritation 43 43
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 41 56
Swelling/ Edema 38 38
Hypoglycemia 34 36
Injury 31 32
Hypersensitivity/Allergic reaction 24 24
Laceration(s) 21 25
Chemical Exposure 20 20
Erythema 19 20
Anxiety 18 18
Skin Tears 15 15
Dizziness 15 15
Missed Dose 15 15
Rash 15 16
Itching Sensation 14 15
Endophthalmitis 14 14
Swelling 14 14
Bacterial Infection 14 14
Unspecified Tissue Injury 14 14
Diabetic Ketoacidosis 13 14
Hematoma 13 13
Easy Bruising 13 13
Unspecified Infection 12 12
Blood Loss 12 12
Visual Impairment 11 12
Fever 10 10
Irritation 10 10
Nerve Damage 10 10
Abscess 10 10
Subcutaneous Nodule 10 10
Reaction 9 9
Inflammation 9 9

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 Embecta Corp. II Jul-23-2024
17 Greiner Bio-One GmbH II Jan-03-2025
18 Guangzhou Improve Medical Instruments Co., Ltd. II Apr-24-2019
19 Owen Mumford USA, Inc. II Jul-15-2021
20 Retractable Technologies, Inc. II Mar-14-2024
21 Smiths Medical ASD Inc. II Jun-04-2019
22 Teleflex Medical II Dec-16-2019
23 Terumo Medical Corporation II Jul-22-2019
24 Waismed Ltd. II Jul-17-2025
25 Zhejiang Kindly Medical Devices Co., Ltd. II Nov-05-2021
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