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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 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
CC BIOTECHNOLOGY CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
CHIRANA T. INJECTA
  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 2
SHINA CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SICHUAN PRIUS BIOTECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SMITHS MEDICAL ASD, INC.
  SUBSTANTIALLY EQUIVALENT 1
TELEFLEX MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
TERUMO EUROPE N.V.
  SUBSTANTIALLY EQUIVALENT 1
TIANJIN HUAHONG TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
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 4243 4243
2021 4528 4528
2022 4886 4887
2023 4990 4990
2024 4057 4057
2025 525 525

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Deliver 5409 5409
Complete Blockage 3048 3048
Break 2614 2614
Leak/Splash 1892 1892
Device Contamination with Chemical or Other Material 1261 1261
Defective Device 841 841
Misconnection 774 774
Fluid/Blood Leak 630 630
Detachment of Device or Device Component 616 617
Device Markings/Labelling Problem 584 584
Defective Component 500 500
Difficult or Delayed Activation 468 468
Material Protrusion/Extrusion 331 331
Packaging Problem 320 320
Product Quality Problem 308 308
Component Missing 252 252
Contamination 251 251
Material Twisted/Bent 249 249
Failure to Cut 220 220
Separation Problem 207 207
Obstruction of Flow 207 207
Material Separation 203 203
No Flow 191 191
Delivered as Unsterile Product 185 185
Adverse Event Without Identified Device or Use Problem 180 180
Physical Resistance/Sticking 172 172
Partial Blockage 153 153
Fail-Safe Problem 139 139
Crack 139 139
Material Deformation 130 130
Failure to Prime 122 122
Material Puncture/Hole 110 110
Power Problem 105 105
Loose or Intermittent Connection 89 89
Retraction Problem 88 88
Missing Information 84 84
Fail-Safe Did Not Operate 82 82
Dull, Blunt 80 80
Activation Problem 74 74
Difficult to Remove 70 70
Volume Accuracy Problem 63 63
Incomplete or Inadequate Connection 58 58
Malposition of Device 58 58
Off-Label Use 58 58
Infusion or Flow Problem 55 55
Insufficient Information 54 54
Material Fragmentation 52 52
Device Misassembled During Manufacturing /Shipping 52 52
Contamination /Decontamination Problem 51 51
Disconnection 50 50

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 16534 16535
No Consequences Or Impact To Patient 2006 2006
No Known Impact Or Consequence To Patient 1432 1432
Needle Stick/Puncture 926 926
Insufficient Information 799 799
No Patient Involvement 606 606
Foreign Body In Patient 354 354
Hyperglycemia 247 247
Pain 235 235
Exposure to Body Fluids 90 90
Device Embedded In Tissue or Plaque 77 77
No Information 61 61
Bruise/Contusion 46 46
Hemorrhage/Bleeding 42 42
Skin Inflammation/ Irritation 40 40
Discomfort 37 37
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 37 37
Swelling/ Edema 36 36
Injection Site Reaction 32 32
Hypoglycemia 27 27
Injury 23 23
Underdose 23 23
Hypersensitivity/Allergic reaction 17 17
Chemical Exposure 17 17
Laceration(s) 16 16
Anxiety 14 14
No Code Available 12 12
Bacterial Infection 12 12
Erythema 12 12
Easy Bruising 12 12
Skin Tears 11 11
Unspecified Tissue Injury 11 11
Hematoma 11 11
Itching Sensation 11 11
Irritation 10 10
Endophthalmitis 10 10
Subcutaneous Nodule 10 10
Diabetic Ketoacidosis 10 10
Visual Impairment 10 10
Hypopyon 8 8
Fever 8 8
Skin Infection 7 7
Inflammation 7 7
Dizziness 7 7
Blood Loss 6 6
Unspecified Infection 6 6
Abscess 5 5
Extravasation 5 5
Missed Dose 4 4
Swelling 4 4

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 Zhejiang Kindly Medical Devices Co., Ltd. II Nov-05-2021
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