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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
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 2
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 3
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
NIPRO MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
NOVO NORDISK INC.
  SUBSTANTIALLY EQUIVALENT 4
OCUJECT, LLC
  SUBSTANTIALLY EQUIVALENT 3
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
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
SOL-MILLENNIUM MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
TELEFLEX MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
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
WEPON MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
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 2397 2397
2019 4894 4894
2020 4243 4243
2021 4528 4528
2022 4885 4886
2023 4301 4301

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Deliver 5579 5579
Break 2872 2872
Complete Blockage 2713 2713
Leak/Splash 2508 2508
Device Contamination with Chemical or Other Material 1575 1575
Misconnection 926 926
Defective Device 862 862
Device Markings/Labelling Problem 705 705
Fluid/Blood Leak 628 628
Difficult or Delayed Activation 558 558
Detachment of Device or Device Component 541 542
Material Protrusion/Extrusion 420 420
Packaging Problem 379 379
Defective Component 377 377
Material Twisted/Bent 374 374
Product Quality Problem 348 348
Component Missing 329 329
Obstruction of Flow 308 308
Failure to Cut 259 259
Delivered as Unsterile Product 227 227
Adverse Event Without Identified Device or Use Problem 223 223
Power Problem 223 223
Contamination 215 215
Separation Problem 200 200
Crack 196 196
Material Separation 185 185
Infusion or Flow Problem 182 182
Material Deformation 172 172
Physical Resistance/Sticking 166 166
Contamination /Decontamination Problem 147 147
Fail-Safe Problem 140 140
Partial Blockage 138 138
Device Damaged Prior to Use 136 136
Dull, Blunt 124 124
Failure to Prime 123 123
Material Puncture/Hole 113 113
No Flow 112 112
Retraction Problem 111 111
Loose or Intermittent Connection 104 104
Fail-Safe Did Not Operate 102 102
Volume Accuracy Problem 101 101
Device Operational Issue 92 92
Mechanical Problem 87 87
Difficult to Remove 85 85
Detachment Of Device Component 80 80
Missing Information 80 80
Device Contaminated During Manufacture or Shipping 74 74
Use of Device Problem 73 73
Activation Problem 69 69
Appropriate Term/Code Not Available 64 64
Device Operates Differently Than Expected 64 64
Manufacturing, Packaging or Shipping Problem 63 63
Incomplete or Inadequate Connection 62 62
Material Fragmentation 62 62
Separation Failure 60 60
Protective Measures Problem 60 60
Device Misassembled During Manufacturing /Shipping 59 59
Occlusion Within Device 57 57
Difficult to Open or Close 53 53
Fitting Problem 52 52
Device Dislodged or Dislocated 50 50
Mechanical Jam 50 50
Complete Loss of Power 48 48
Disconnection 48 48
Material Integrity Problem 47 47
Unsealed Device Packaging 46 46
Patient-Device Incompatibility 44 44
Difficult to Insert 42 42
Entrapment of Device 40 40
Connection Problem 40 40
Bent 39 39
Tear, Rip or Hole in Device Packaging 38 38
Improper or Incorrect Procedure or Method 38 38
Nonstandard Device 35 35
Physical Property Issue 35 35
Insufficient Information 35 35
Insufficient Flow or Under Infusion 34 34
Device Difficult to Setup or Prepare 34 34
Activation Failure 31 31
Illegible Information 29 29
Inadequacy of Device Shape and/or Size 27 27
Inaccurate Information 26 26
Improper Flow or Infusion 26 26
Contamination of Device Ingredient or Reagent 23 23
Failure to Infuse 23 23
Structural Problem 23 23
Malposition of Device 22 22
Material Perforation 22 22
Difficult or Delayed Positioning 22 22
Device Slipped 21 21
Inaccurate Delivery 21 21
Shielding Failure 20 20
Positioning Failure 20 20
Failure To Adhere Or Bond 19 19
Incomplete or Missing Packaging 19 19
Fungus in Device Environment 18 18
Failure to Disconnect 18 18
Incorrect, Inadequate or Imprecise Result or Readings 18 18
Loss of or Failure to Bond 18 18
Device Fell 18 18

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 12011 12012
No Known Impact Or Consequence To Patient 6590 6590
No Consequences Or Impact To Patient 2553 2553
Needle Stick/Puncture 976 976
No Patient Involvement 829 829
Insufficient Information 529 529
No Information 524 524
Foreign Body In Patient 356 356
Hyperglycemia 282 282
Pain 282 282
Exposure to Body Fluids 128 128
Device Embedded In Tissue or Plaque 121 121
No Code Available 93 93
Bruise/Contusion 78 78
Underdose 70 70
Hemorrhage/Bleeding 54 54
Hypoglycemia 35 35
Discomfort 35 35
Injury 34 34
Skin Inflammation/ Irritation 32 32
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 28 28
Hypersensitivity/Allergic reaction 27 27
Missed Dose 22 22
Injection Site Reaction 22 22
Chemical Exposure 21 21
Laceration(s) 19 19
Swelling 19 19
Unspecified Infection 18 18
Swelling/ Edema 18 18
Rash 17 17
Erythema 17 17
Blood Loss 17 17
Anxiety 17 17
Skin Tears 14 14
Bacterial Infection 14 14
Diabetic Ketoacidosis 13 13
Reaction 13 13
Inflammation 12 12
Hematoma 11 11
Itching Sensation 11 11
Dizziness 11 11
Missing Value Reason 11 11
Easy Bruising 11 11
Subcutaneous Nodule 10 10
Visual Impairment 10 10
Burning Sensation 10 10
Irritation 10 10
Nerve Damage 10 10
Overdose 10 10
Endophthalmitis 10 10
Fever 9 9
Reaction, Injection Site 9 9
Unspecified Tissue Injury 9 9
Hypopyon 8 8
Skin Irritation 7 7
Abscess 7 7
Patient Problem/Medical Problem 7 7
Nausea 6 6
Scarring 5 5
Tissue Damage 5 5
Headache 5 5
Skin Infection 5 5
Distress 5 5
Skin Inflammation 4 4
Extravasation 4 4
Vessel Or Plaque, Device Embedded In 4 4
Death 4 4
Local Reaction 4 4
Neuropathy 3 3
Sepsis 3 3
Miscarriage 3 3
Muscle Weakness 3 3
High Blood Pressure/ Hypertension 3 3
Infiltration into Tissue 3 3
Cellulitis 3 3
Fall 3 3
Fatigue 3 3
Inadequate Pain Relief 3 3
Premature Labor 3 3
Urticaria 3 3
Syncope/Fainting 3 3
Respiratory Arrest 3 3
Blister 2 2
Weight Changes 2 2
Not Applicable 2 2
Test Result 2 2
Abdominal Cramps 2 2
Confusion/ Disorientation 2 2
Post Operative Wound Infection 2 2
Coma 2 2
Electrolyte Imbalance 2 2
Malaise 2 2
Complaint, Ill-Defined 2 2
Vomiting 2 2
Hepatitis 2 2
Eye Injury 2 2
Fainting 2 2
Emotional Changes 2 2
Cardiac Arrest 2 2
Dehydration 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Apellis Pharmaceuticals, Inc. II Sep-29-2023
2 Arrow International Inc II May-30-2018
3 Arrow International Inc II Feb-13-2018
4 B. Braun Medical, Inc. II Feb-09-2018
5 Bard Access Systems, Inc. I Jul-22-2022
6 Bard Peripheral Vascular Inc II Oct-01-2021
7 Becton Dickinson & Company II Dec-15-2020
8 Becton Dickinson & Company II Nov-27-2020
9 Becton Dickinson & Company II Aug-27-2020
10 Becton Dickinson & Company II Oct-31-2019
11 Becton Dickinson & Company II Oct-24-2019
12 Becton Dickinson & Company II Jul-22-2019
13 Becton Dickinson & Company II Oct-11-2018
14 C.A. Greiner & Sohne Gesellschaftmbh II Aug-28-2020
15 Cardinal Health 200, LLC II Mar-15-2021
16 Cardinal Health 200, LLC II Nov-05-2020
17 Cardinal Health 200, LLC II Mar-09-2020
18 Cardinal Health 200, LLC II Jul-23-2019
19 Cardinal Health Inc. II Jun-23-2021
20 Centurion Medical Products Corporation II Jan-04-2018
21 Guangzhou Improve Medical Instruments Co., Ltd. II Apr-24-2019
22 Guangzhou Improve Medical Instruments Co., Ltd. II Aug-12-2018
23 Guangzhou Improve Medical Instruments Co., Ltd. II Jul-26-2018
24 MHC Medical Products LLC II May-09-2018
25 Owen Mumford USA, Inc. II Jul-15-2021
26 Owen Mumford USA, Inc. II Jan-17-2018
27 Smiths Medical ASD Inc. II Jun-04-2019
28 Teleflex Medical II Dec-16-2019
29 Terumo Medical Corporation II Jul-22-2019
30 Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. II Feb-21-2018
31 Zhejiang Kindly Medical Devices Co., Ltd. II Nov-05-2021
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