Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 1
ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
ANHUI TIANKANG MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
AZUR MEDICAL COMPANY INC.
  SUBSTANTIALLY EQUIVALENT 1
BECTON DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 1
BECTON, DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 1
BECTON, DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 2
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
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
OWEN MUMFORD LTD
  SUBSTANTIALLY EQUIVALENT 1
PIKDARE S.P.A
  SUBSTANTIALLY EQUIVALENT 1
PIKDARE SPA
  SUBSTANTIALLY EQUIVALENT 1
POONGLIM PHARMATECH INC.
  SUBSTANTIALLY EQUIVALENT 1
PROMAMEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
PROMISEMED HANGZHOU MEDITECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 9
SANDSTONE MEDICAL (SUZHOU) INC.
  SUBSTANTIALLY EQUIVALENT 2
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 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 1
ZHEJIANG KINDLY MEDICAL DEVICES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZIEN MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 4245 4264
2021 4532 4581
2022 4885 4932
2023 4986 5011
2024 4053 4053
2025 2174 2174

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Deliver 5658 5662
Complete Blockage 3077 3077
Break 2809 2840
Leak/Splash 2063 2067
Device Contamination with Chemical or Other Material 1299 1299
Defective Device 897 910
Misconnection 809 809
Fluid/Blood Leak 701 711
Detachment of Device or Device Component 636 664
Device Markings/Labelling Problem 609 613
Defective Component 566 578
Difficult or Delayed Activation 554 554
Material Protrusion/Extrusion 346 346
Product Quality Problem 338 343
Packaging Problem 330 334
Material Twisted/Bent 312 341
Contamination 292 292
Component Missing 269 276
Material Separation 233 237
Failure to Cut 221 221
Obstruction of Flow 219 222
No Flow 215 215
Separation Problem 210 211
Adverse Event Without Identified Device or Use Problem 196 198
Delivered as Unsterile Product 195 195
Physical Resistance/Sticking 178 182
Partial Blockage 161 161
Fail-Safe Problem 155 156
Crack 145 146
Material Deformation 140 140
Off-Label Use 138 138
Failure to Prime 122 122
Dull, Blunt 120 146
Material Puncture/Hole 119 121
Contamination /Decontamination Problem 105 105
Power Problem 105 105
Activation Problem 103 103
Difficult to Remove 102 102
Loose or Intermittent Connection 95 100
Retraction Problem 91 91
Fail-Safe Did Not Operate 89 116
Malposition of Device 85 85
Missing Information 84 84
Connection Problem 70 70
Insufficient Information 68 68
Disconnection 66 70
Volume Accuracy Problem 62 62
Premature Activation 61 61
Incomplete or Inadequate Connection 60 60
Material Fragmentation 60 60

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 17826 17875
No Consequences Or Impact To Patient 2006 2006
No Known Impact Or Consequence To Patient 1432 1437
Needle Stick/Puncture 1058 1088
Insufficient Information 875 899
No Patient Involvement 606 606
Foreign Body In Patient 408 412
Pain 258 263
Hyperglycemia 257 257
Exposure to Body Fluids 90 90
Device Embedded In Tissue or Plaque 88 90
Hemorrhage/Bleeding 64 64
No Information 61 61
Bruise/Contusion 48 49
Injection Site Reaction 42 42
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 41 56
Skin Inflammation/ Irritation 41 41
Discomfort 38 38
Swelling/ Edema 36 36
Hypoglycemia 29 31
Injury 23 24
Underdose 23 23
Hypersensitivity/Allergic reaction 17 17
Chemical Exposure 17 17
Laceration(s) 15 19
Anxiety 15 15
Unspecified Tissue Injury 14 14
Skin Tears 14 14
Erythema 13 14
Endophthalmitis 13 13
Easy Bruising 13 13
Bacterial Infection 13 13
No Code Available 12 12
Hematoma 11 11
Itching Sensation 11 12
Visual Impairment 11 12
Diabetic Ketoacidosis 10 11
Irritation 10 10
Subcutaneous Nodule 10 10
Rash 9 10
Dizziness 8 8
Fever 8 8
Hypopyon 8 8
Inflammation 7 7
Skin Infection 7 7
Unspecified Infection 6 6
Blood Loss 6 6
Immunodeficiency 5 5
Extravasation 5 5
Abscess 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
-
-