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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
Product CodeFMI
Regulation Number 880.5570
Device Class 2


Premarket Reviews
ManufacturerDecision
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
ANHUI TIANKANG MEDICAL TECHNOLOGY CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
AZUR MEDICAL COMPANY INC.
  SUBSTANTIALLY EQUIVALENT 1
BARD ACCESS SYSTEMS, INC(BAS)[WHOLLY-OWNED SUBSIDIARY OF BD]
  SUBSTANTIALLY EQUIVALENT 1
BECTON DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 1
BECTON, DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 1
BECTON, DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 3
BERPU MEDICAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
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
EINSTEIN WORKS, L.L.C
  SUBSTANTIALLY EQUIVALENT 1
EINSTEIN WORKS, L.L.C.
  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
OCUJET, LLC
  SUBSTANTIALLY EQUIVALENT 1
OWEN MUMFORD LTD
  SUBSTANTIALLY EQUIVALENT 1
PIKDARE S.P.A
  SUBSTANTIALLY EQUIVALENT 1
PIKDARE SPA
  SUBSTANTIALLY EQUIVALENT 1
PIPER ACCESS, LLC
  SUBSTANTIALLY EQUIVALENT 1
POONGLIM PHARMATECH INC.
  SUBSTANTIALLY EQUIVALENT 1
PROMAMEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
PROMISEMED HANGZHOU MEDITECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 8
SAM® MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
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 2
TIANJIN HUAHONG TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
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 1
ZHEJIANG KINDLY MEDICAL DEVICES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZIEN MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 4894 4894
2020 4243 4243
2021 4528 4528
2022 4887 4888
2023 4991 4991
2024 2551 2551

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Deliver 6213 6213
Complete Blockage 3059 3059
Break 2905 2905
Leak/Splash 2370 2370
Device Contamination with Chemical or Other Material 1513 1513
Misconnection 1025 1025
Defective Device 928 928
Device Markings/Labelling Problem 720 720
Difficult or Delayed Activation 621 621
Fluid/Blood Leak 603 603
Detachment of Device or Device Component 573 574
Defective Component 457 457
Material Protrusion/Extrusion 426 426
Packaging Problem 394 394
Product Quality Problem 383 383
Material Twisted/Bent 325 325
Component Missing 308 308
Failure to Cut 273 273
Delivered as Unsterile Product 236 236
Obstruction of Flow 233 233
Contamination 227 227
Separation Problem 218 218
Adverse Event Without Identified Device or Use Problem 212 212
Material Separation 188 188
No Flow 187 187
Physical Resistance/Sticking 185 185
Crack 174 174
Power Problem 161 161
Material Deformation 147 147
Partial Blockage 144 144
Fail-Safe Problem 135 135
Failure to Prime 124 124
Material Puncture/Hole 118 118
Dull, Blunt 116 116
Device Damaged Prior to Use 113 113
Fail-Safe Did Not Operate 98 98
Loose or Intermittent Connection 98 98
Retraction Problem 95 95
Volume Accuracy Problem 93 93
Contamination /Decontamination Problem 93 93
Missing Information 84 84
Activation Problem 79 79
Infusion or Flow Problem 76 76
Difficult to Remove 73 73
Material Fragmentation 67 67
Incomplete or Inadequate Connection 66 66
Device Misassembled During Manufacturing /Shipping 64 64
Mechanical Problem 58 58
Mechanical Jam 55 55
Fitting Problem 54 54

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 14804 14805
No Known Impact Or Consequence To Patient 5124 5124
No Consequences Or Impact To Patient 2237 2237
Needle Stick/Puncture 999 999
No Patient Involvement 759 759
Insufficient Information 690 690
Foreign Body In Patient 374 374
No Information 334 334
Pain 299 299
Hyperglycemia 279 279
Exposure to Body Fluids 116 116
Device Embedded In Tissue or Plaque 109 109
Bruise/Contusion 69 69
Underdose 65 65
Hemorrhage/Bleeding 55 55
No Code Available 46 46
Discomfort 38 38
Skin Inflammation/ Irritation 38 38
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 33 33
Hypoglycemia 32 32
Injury 31 31
Swelling/ Edema 31 31
Injection Site Reaction 29 29
Hypersensitivity/Allergic reaction 23 23
Laceration(s) 20 20
Chemical Exposure 17 17
Anxiety 17 17
Erythema 16 16
Missed Dose 15 15
Swelling 13 13
Bacterial Infection 13 13
Blood Loss 12 12
Itching Sensation 12 12
Hematoma 12 12
Dizziness 12 12
Diabetic Ketoacidosis 12 12
Skin Tears 12 12
Unspecified Infection 11 11
Easy Bruising 11 11
Irritation 10 10
Endophthalmitis 10 10
Unspecified Tissue Injury 10 10
Subcutaneous Nodule 10 10
Nerve Damage 10 10
Visual Impairment 10 10
Inflammation 9 9
Reaction 9 9
Overdose 9 9
Fever 8 8
Hypopyon 8 8

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 Guangzhou Improve Medical Instruments Co., Ltd. II Apr-24-2019
18 Owen Mumford USA, Inc. II Jul-15-2021
19 Retractable Technologies, Inc. II Mar-14-2024
20 Smiths Medical ASD Inc. II Jun-04-2019
21 Teleflex Medical II Dec-16-2019
22 Terumo Medical Corporation II Jul-22-2019
23 Zhejiang Kindly Medical Devices Co., Ltd. II Nov-05-2021
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