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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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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 1
ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
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 1
BECTON, DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 5
BERPU MEDICAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
BERPU MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
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
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 2
JIANGSU CAINA MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
JIANGSU SHENLI MEDICAL PRODUCTION CO., LTD
  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
NINGBO MEDSUN MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
NOVO NORDISK INC.
  SUBSTANTIALLY EQUIVALENT 3
OCUJECT, LLC
  SUBSTANTIALLY EQUIVALENT 1
OCUJET, LLC
  SUBSTANTIALLY EQUIVALENT 1
OWEN MUMFORD LTD
  SUBSTANTIALLY EQUIVALENT 2
PIKDARE S.P.A
  SUBSTANTIALLY EQUIVALENT 1
PIKDARE SPA
  SUBSTANTIALLY EQUIVALENT 1
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
SICHUAN PRIUS BIOTECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
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
ZHEJIANG KANGKANG MEDICAL-DEVICES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
ZHEJIANG KINDLY MEDICAL DEVICES CO. LTD
  SUBSTANTIALLY EQUIVALENT 2
ZHEJIANG KINDLY MEDICAL DEVICES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 2396 2396
2019 4894 4894
2020 4243 4243
2021 4528 4528
2022 4886 4887

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Deliver 4841 4841
Break 2358 2358
Leak/Splash 2287 2287
Complete Blockage 1724 1724
Device Contamination with Chemical or Other Material 1434 1434
Misconnection 914 914
Defective Device 780 780
Device Markings/Labelling Problem 628 628
Fluid/Blood Leak 544 544
Difficult or Delayed Activation 525 525
Detachment of Device or Device Component 463 464
Material Protrusion/Extrusion 400 400
Material Twisted/Bent 346 346
Packaging Problem 345 345
Product Quality Problem 322 322
Component Missing 279 279
Obstruction of Flow 240 240
Power Problem 223 223
Failure to Cut 220 220
Defective Component 220 220
Delivered as Unsterile Product 210 210
Adverse Event Without Identified Device or Use Problem 193 193
Infusion or Flow Problem 172 172
Crack 163 163
Material Deformation 157 157
Contamination /Decontamination Problem 145 145
Device Damaged Prior to Use 136 136
Material Separation 122 122
Dull, Blunt 109 109
Physical Resistance/Sticking 109 109
Fail-Safe Problem 108 108
Volume Accuracy Problem 100 100
Separation Problem 98 98
Device Operational Issue 92 92
Retraction Problem 88 88
Partial Blockage 86 86
Fail-Safe Did Not Operate 82 82
Detachment Of Device Component 80 80
Difficult to Remove 77 77
Mechanical Problem 74 74
Loose or Intermittent Connection 73 73
Contamination 72 72
Material Puncture/Hole 72 72
No Flow 72 72
Device Contaminated During Manufacture or Shipping 71 71
Use of Device Problem 71 71
Device Operates Differently Than Expected 64 64
Appropriate Term/Code Not Available 63 63
Activation Problem 58 58
Occlusion Within Device 57 57
Missing Information 56 56
Device Misassembled During Manufacturing /Shipping 55 55
Incomplete or Inadequate Connection 50 50
Separation Failure 50 50
Device Dislodged or Dislocated 49 49
Manufacturing, Packaging or Shipping Problem 46 46
Protective Measures Problem 46 46
Material Fragmentation 46 46
Mechanical Jam 45 45
Difficult to Open or Close 42 42
Patient-Device Incompatibility 42 42
Material Integrity Problem 41 41
Disconnection 40 40
Bent 39 39
Connection Problem 37 37
Entrapment of Device 36 36
Unsealed Device Packaging 36 36
Difficult to Insert 35 35
Physical Property Issue 35 35
Complete Loss of Power 34 34
Improper or Incorrect Procedure or Method 33 33
Insufficient Flow or Under Infusion 31 31
Fitting Problem 31 31
Insufficient Information 31 31
Tear, Rip or Hole in Device Packaging 30 30
Nonstandard Device 28 28
Illegible Information 27 27
Device Difficult to Setup or Prepare 26 26
Improper Flow or Infusion 25 25
Failure to Prime 24 24
Inadequacy of Device Shape and/or Size 24 24
Failure to Infuse 23 23
Difficult or Delayed Positioning 22 22
Device Slipped 21 21
Activation Failure 21 21
Shielding Failure 20 20
Structural Problem 20 20
Malposition of Device 19 19
Inaccurate Delivery 19 19
Positioning Failure 19 19
Failure To Adhere Or Bond 19 19
Incorrect, Inadequate or Imprecise Result or Readings 18 18
Material Perforation 17 17
Fungus in Device Environment 16 16
Output Problem 16 16
Device Fell 16 16
Inaccurate Information 15 15
Incomplete or Missing Packaging 15 15
Contamination of Device Ingredient or Reagent 15 15
Loss of or Failure to Bond 15 15

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 8279 8280
No Known Impact Or Consequence To Patient 6590 6590
No Consequences Or Impact To Patient 2553 2553
No Patient Involvement 829 829
Needle Stick/Puncture 814 814
No Information 524 524
Insufficient Information 335 335
Foreign Body In Patient 300 300
Pain 240 240
Hyperglycemia 240 240
Exposure to Body Fluids 119 119
Device Embedded In Tissue or Plaque 109 109
No Code Available 93 93
Bruise/Contusion 74 74
Underdose 70 70
Hemorrhage/Bleeding 44 44
Hypoglycemia 34 34
Injury 34 34
Hypersensitivity/Allergic reaction 26 26
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 24 24
Skin Inflammation/ Irritation 23 23
Missed Dose 22 22
Discomfort 21 21
Swelling 19 19
Chemical Exposure 18 18
Blood Loss 17 17
Unspecified Infection 17 17
Rash 16 16
Injection Site Reaction 16 16
Anxiety 15 15
Laceration(s) 14 14
Bacterial Infection 14 14
Erythema 14 14
Reaction 13 13
Diabetic Ketoacidosis 12 12
Skin Tears 12 12
Inflammation 12 12
Dizziness 11 11
Missing Value Reason 11 11
Subcutaneous Nodule 10 10
Swelling/ Edema 10 10
Irritation 10 10
Itching Sensation 10 10
Nerve Damage 10 10
Overdose 10 10
Visual Impairment 10 10
Burning Sensation 10 10
Hematoma 10 10
Reaction, Injection Site 9 9
Endophthalmitis 8 8
Hypopyon 8 8
Skin Irritation 7 7
Patient Problem/Medical Problem 7 7
Nausea 6 6
Abscess 6 6
Tissue Damage 5 5
Scarring 5 5
Local Reaction 4 4
Vessel Or Plaque, Device Embedded In 4 4
Death 4 4
Skin Inflammation 4 4
Distress 3 3
Premature Labor 3 3
Urticaria 3 3
Unspecified Tissue Injury 3 3
Respiratory Arrest 3 3
Cellulitis 3 3
Extravasation 3 3
Headache 3 3
Fever 3 3
High Blood Pressure/ Hypertension 3 3
Sepsis 3 3
Neuropathy 3 3
Infiltration into Tissue 3 3
Miscarriage 3 3
Respiratory Distress 2 2
Blurred Vision 2 2
Vomiting 2 2
Hepatitis 2 2
Eye Injury 2 2
Fainting 2 2
Fall 2 2
Fatigue 2 2
Purulent Discharge 2 2
Abdominal Pain 2 2
Air Embolism 2 2
Anaphylactic Shock 2 2
Not Applicable 2 2
Syncope/Fainting 2 2
Abdominal Cramps 2 2
Confusion/ Disorientation 2 2
Test Result 2 2
Electrolyte Imbalance 2 2
Complaint, Ill-Defined 2 2
Malaise 2 2
Post Operative Wound Infection 2 2
Inadequate Pain Relief 1 1
Numbness 1 1
Coma 1 1
Loss of consciousness 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 C.A. Greiner & Sohne Gesellschaftmbh II Aug-28-2020
14 Cardinal Health 200, LLC II Mar-15-2021
15 Cardinal Health 200, LLC II Nov-05-2020
16 Cardinal Health 200, LLC II Mar-09-2020
17 Cardinal Health 200, LLC II Jul-23-2019
18 Cardinal Health Inc. II Jun-23-2021
19 Centurion Medical Products Corporation II Jan-04-2018
20 Guangzhou Improve Medical Instruments Co., Ltd. II Apr-24-2019
21 Guangzhou Improve Medical Instruments Co., Ltd. II Aug-12-2018
22 Guangzhou Improve Medical Instruments Co., Ltd. II Jul-26-2018
23 MHC Medical Products LLC II May-09-2018
24 Owen Mumford USA, Inc. II Jul-15-2021
25 Owen Mumford USA, Inc. II Jan-17-2018
26 Smiths Medical ASD Inc. II Jun-04-2019
27 Teleflex Medical II Dec-16-2019
28 Terumo Medical Corporation II Jul-22-2019
29 Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. II Feb-21-2018
30 Zhejiang Kindly Medical Devices Co., Ltd. II Nov-05-2021
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