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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
Device needle, hypodermic, single lumen
Product CodeFMI
Regulation Number 880.5570
Device Class 2


Premarket Reviews
ManufacturerDecision
ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ANHUI TIANKANG MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ANHUI TIANKANG MEDICAL TECHNOLOGY CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, INC.)
  SUBSTANTIALLY EQUIVALENT 1
AZUR MEDICAL COMPANY INC.
  SUBSTANTIALLY EQUIVALENT 1
B. BRAUN MEDICAL 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 5
BERPU MEDICAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
BERPU MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BIOTEKNE SRL
  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
GEMTIER MEDICAL (SHANGHAI) INC.
  SUBSTANTIALLY EQUIVALENT 1
GREINER BIO-ONE NA INC
  SUBSTANTIALLY EQUIVALENT 1
GREINER BIO-ONE NA INC.
  SUBSTANTIALLY EQUIVALENT 1
HANTECH MEDICAL DEVICE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HTL STREFA SA
  SUBSTANTIALLY EQUIVALENT 1
HTL-STREFA S.A
  SUBSTANTIALLY EQUIVALENT 1
HTL-STREFA S.A.
  SUBSTANTIALLY EQUIVALENT 3
JIANGSU CAINA MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
JIANGSU CAINA TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU SHENLI MEDICAL PRODUCTION CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
MEDBIO LLC.
  SUBSTANTIALLY EQUIVALENT 1
MEDEXEL CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDIBIO USA LLC.
  SUBSTANTIALLY EQUIVALENT 1
MHC MEDICAL PRODUCTS, LLC.
  SUBSTANTIALLY EQUIVALENT 1
MYCO MEDICAL SUPPLIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
NOVO NORDISK INC.
  SUBSTANTIALLY EQUIVALENT 3
OCUJECT, LLC
  SUBSTANTIALLY EQUIVALENT 2
OCUJET, LLC
  SUBSTANTIALLY EQUIVALENT 1
OWEN MUMFORD LTD
  SUBSTANTIALLY EQUIVALENT 2
PIPER ACCESS, LLC
  SUBSTANTIALLY EQUIVALENT 1
POONGLIM PHARMATECH INC.
  SUBSTANTIALLY EQUIVALENT 2
PROMISEMED HANGZHOU MEDITECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 7
SAM® MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SANDSTONE MEDICAL (SUZHOU) INC.
  SUBSTANTIALLY EQUIVALENT 2
SHANGHAI KINDLY ENTERPRISE DEVELOPMENT GROUP CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SMITHS MEDICAL ASD, INC.
  SUBSTANTIALLY EQUIVALENT 1
SOL-MILLENNIUM MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
TELEFLEX MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
TERUMO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
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
YPSOMED AG
  SUBSTANTIALLY EQUIVALENT 1
ZHEJIANG KANGKANG MEDICAL-DEVICES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
ZHEJIANG KINDLY MEDICAL DEVICES CO. LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 1547 1547
2018 2396 2396
2019 4894 4894
2020 4243 4243
2021 4528 4528
2022 2817 2817

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Deliver 4539 4539
Break 2401 2401
Leak/Splash 2325 2325
Device Contamination with Chemical or Other Material 1521 1521
Complete Blockage 1074 1074
Misconnection 887 887
Defective Device 745 745
Device Markings/Labelling Problem 616 616
Fluid Leak 599 599
Difficult or Delayed Activation 524 524
Detachment of Device or Device Component 466 466
Material Protrusion/Extrusion 401 401
Packaging Problem 344 344
Material Twisted/Bent 329 329
Product Quality Problem 318 318
Detachment Of Device Component 298 298
Power Problem 296 296
Component Missing 268 268
Crack 213 213
Adverse Event Without Identified Device or Use Problem 208 208
Delivered as Unsterile Product 205 205
Failure to Cut 202 202
Device Operates Differently Than Expected 177 177
Infusion or Flow Problem 177 177
Defective Component 171 171
Obstruction of Flow 154 154
Material Deformation 150 150
Device Damaged Prior to Use 147 147
Contamination /Decontamination Problem 145 145
Fail-Safe Problem 137 137
Material Separation 127 127
Dull, Blunt 107 107
Protective Measures Problem 105 105
Retraction Problem 103 103
Volume Accuracy Problem 97 97
Difficult to Remove 94 94
Device Operational Issue 92 92
Loose or Intermittent Connection 83 83
Bent 81 81
Use of Device Problem 80 80
Device Contaminated During Manufacture or Shipping 80 80
Physical Resistance/Sticking 76 76
Separation Problem 75 75
Fail-Safe Did Not Operate 75 75
Mechanical Problem 74 74
Partial Blockage 68 68
Material Puncture/Hole 65 65
Appropriate Term/Code Not Available 65 65
Device Dislodged or Dislocated 60 60
Occlusion Within Device 60 60
Separation Failure 59 59
Device Misassembled During Manufacturing /Shipping 53 53
No Flow 52 52
Connection Problem 51 51
Improper or Incorrect Procedure or Method 51 51
Component Falling 51 51
Insufficient Information 49 49
Patient-Device Incompatibility 47 47
Manufacturing, Packaging or Shipping Problem 47 47
Difficult to Open or Close 46 46
Incomplete or Inadequate Connection 45 45
Activation Problem 45 45
Material Fragmentation 45 45
Disconnection 44 44
Missing Information 43 43
Material Integrity Problem 42 42
Mechanical Jam 41 41
Contamination 41 41
Entrapment of Device 38 38
Unsealed Device Packaging 38 38
Physical Property Issue 36 36
Fitting Problem 31 31
Difficult to Insert 31 31
Tear, Rip or Hole in Device Packaging 28 28
Device Slipped 28 28
Insufficient Flow or Under Infusion 27 27
Nonstandard Device 26 26
Fail-Safe Design Failure 25 25
Complete Loss of Power 25 25
Inadequacy of Device Shape and/or Size 24 24
Failure to Infuse 23 23
Illegible Information 23 23
Difficult or Delayed Positioning 22 22
Positioning Failure 22 22
Inaccurate Delivery 21 21
Shielding Failure 21 21
Malposition of Device 21 21
Device Difficult to Setup or Prepare 20 20
Structural Problem 20 20
Failure To Adhere Or Bond 20 20
Material Discolored 18 18
Incorrect, Inadequate or Imprecise Resultor Readings 18 18
Incorrect Device Or Component Shipped 18 18
Improper Flow or Infusion 18 18
Device Or Device Fragments Location Unknown 17 17
Failure to Disconnect 16 16
Fungus in Device Environment 16 16
Loss of or Failure to Bond 16 16
Positioning Problem 16 16
Device Packaging Compromised 16 16

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 7353 7353
No Clinical Signs, Symptoms or Conditions 6383 6383
No Consequences Or Impact To Patient 2876 2876
Needle Stick/Puncture 948 948
No Patient Involvement 907 907
No Information 572 572
Foreign Body In Patient 292 292
Insufficient Information 289 289
Hyperglycemia 241 241
Pain 227 227
Exposure to Body Fluids 153 153
Device Embedded In Tissue or Plaque 147 147
No Code Available 110 110
Bruise/Contusion 74 74
Underdose 71 71
Hemorrhage/Bleeding 44 44
Injury 40 40
Hypoglycemia 31 31
Hypersensitivity/Allergic reaction 26 26
Unspecified Infection 26 26
Discomfort 26 26
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 24 24
Missed Dose 23 23
Swelling 21 21
Skin Inflammation/ Irritation 20 20
Blood Loss 20 20
Chemical Exposure 19 19
Reaction 17 17
Rash 16 16
Laceration(s) 15 15
Anxiety 15 15
Injection Site Reaction 15 15
Diabetic Ketoacidosis 14 14
Bacterial Infection 14 14
Inflammation 12 12
Reaction, Injection Site 12 12
Skin Tears 12 12
Missing Value Reason 11 11
Burning Sensation 11 11
Erythema 11 11
Dizziness 10 10
Visual Impairment 10 10
Nerve Damage 10 10
Overdose 10 10
Irritation 10 10
Itching Sensation 10 10
Hematoma 9 9
Endophthalmitis 8 8
Abscess 8 8
Hypopyon 8 8
Swelling/ Edema 8 8
Patient Problem/Medical Problem 7 7
Skin Irritation 7 7
Scarring 6 6
Nausea 6 6
Not Applicable 6 6
Skin Inflammation 6 6
Infiltration into Tissue 5 5
Tissue Damage 5 5
Death 5 5
Extravasation 4 4
Vessel Or Plaque, Device Embedded In 4 4
Local Reaction 4 4
Distress 4 4
Urticaria 4 4
Complaint, Ill-Defined 3 3
Premature Labor 3 3
Sepsis 3 3
Miscarriage 3 3
Cellulitis 3 3
Fever 3 3
Headache 3 3
Hepatitis 2 2
Eye Injury 2 2
Fainting 2 2
Fall 2 2
Fatigue 2 2
Purulent Discharge 2 2
Air Embolism 2 2
Anaphylactic Shock 2 2
Respiratory Distress 2 2
Neuropathy 2 2
Vomiting 2 2
Electrolyte Imbalance 2 2
Post Operative Wound Infection 2 2
Abdominal Cramps 2 2
Malaise 2 2
Fungal Infection 2 2
Blurred Vision 2 2
Wheal(s) 2 2
Test Result 2 2
Confusion/ Disorientation 2 2
Syncope/Fainting 2 2
Subcutaneous Nodule 2 2
Unspecified Tissue Injury 2 2
Decreased Appetite 1 1
Movement Disorder 1 1
Unspecified Mental, Emotional or Behavioural Problem 1 1
Unspecified Eye / Vision Problem 1 1
Urethral Stenosis/Stricture 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Arrow International Inc II May-30-2018
2 Arrow International Inc II Feb-13-2018
3 B. Braun Medical, Inc. II Feb-09-2018
4 Bard Access Systems, Inc. I Jul-22-2022
5 Bard Peripheral Vascular Inc II Oct-01-2021
6 Becton Dickinson & Company II Dec-15-2020
7 Becton Dickinson & Company II Nov-27-2020
8 Becton Dickinson & Company II Aug-27-2020
9 Becton Dickinson & Company II Oct-31-2019
10 Becton Dickinson & Company II Oct-24-2019
11 Becton Dickinson & Company II Jul-22-2019
12 Becton Dickinson & Company II Oct-11-2018
13 Becton Dickinson & Company II Dec-07-2017
14 Becton Dickinson & Company II Sep-11-2017
15 Becton Dickinson & Company II Jul-19-2017
16 C.A. Greiner & Sohne Gesellschaftmbh II Aug-28-2020
17 Cardinal Health 200, LLC II Mar-15-2021
18 Cardinal Health 200, LLC II Nov-05-2020
19 Cardinal Health 200, LLC II Mar-09-2020
20 Cardinal Health 200, LLC II Jul-23-2019
21 Cardinal Health Inc. II Jun-23-2021
22 Centurion Medical Products Corporation II Jan-04-2018
23 Guangzhou Improve Medical Instruments Co., Ltd. II Apr-24-2019
24 Guangzhou Improve Medical Instruments Co., Ltd. II Aug-12-2018
25 Guangzhou Improve Medical Instruments Co., Ltd. II Jul-26-2018
26 International Medsurg Connection, Inc. II Aug-04-2017
27 MHC Medical Products LLC II May-09-2018
28 Owen Mumford USA, Inc. II Jul-15-2021
29 Owen Mumford USA, Inc. II Jan-17-2018
30 Smiths Medical ASD Inc. II Jun-04-2019
31 Smiths Medical ASD Inc. II Jul-03-2017
32 Teleflex Medical II Dec-16-2019
33 Teleflex Medical III Apr-04-2017
34 Terumo Medical Corporation II Jul-22-2019
35 Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. II Feb-21-2018
36 Zhejiang Kindly Medical Devices Co., Ltd. II Nov-05-2021
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