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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
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 4
BERPU MEDICAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
BIOTEKNE SRL
  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
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 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 1
TIANJIN HUAHONG TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
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
WAISMED LTD
  SUBSTANTIALLY EQUIVALENT 2
YPSOMED AG
  SUBSTANTIALLY EQUIVALENT 1
ZHEJIANG KANGKANG MEDICAL-DEVICES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
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 4242 4242
2021 4515 4515

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Deliver 3907 3907
Leak/Splash 2186 2186
Break 2067 2067
Device Contamination with Chemical or Other Material 1374 1374
Misconnection 818 818
Complete Blockage 699 699
Defective Device 613 613
Device Markings/Labelling Problem 577 577
Fluid Leak 522 522
Difficult or Delayed Activation 490 490
Detachment of Device or Device Component 384 384
Material Protrusion/Extrusion 380 380
Packaging Problem 328 328
Detachment Of Device Component 298 298
Material Twisted/Bent 297 297
Power Problem 296 296
Product Quality Problem 287 287
Component Missing 209 209
Adverse Event Without Identified Device or Use Problem 192 192
Crack 191 191
Delivered as Unsterile Product 187 187
Failure to Cut 184 184
Device Operates Differently Than Expected 177 177
Infusion or Flow Problem 176 176
Contamination /Decontamination Problem 138 138
Device Damaged Prior to Use 137 137
Obstruction of Flow 128 128
Fail-Safe Problem 120 120
Material Deformation 107 107
Material Separation 104 104
Protective Measures Problem 101 101
Dull, Blunt 98 98
Device Operational Issue 92 92
Retraction Problem 86 86
Volume Accuracy Problem 82 82
Bent 81 81
Device Contaminated During Manufacture or Shipping 78 78
Use of Device Problem 75 75
Defective Component 71 71
Mechanical Problem 71 71
Loose or Intermittent Connection 70 70
Difficult to Remove 68 68
Appropriate Term/Code Not Available 64 64
Fail-Safe Did Not Operate 64 64
Occlusion Within Device 60 60
Device Dislodged or Dislocated 53 53
Component Falling 51 51
Separation Failure 51 51
Device Misassembled During Manufacturing /Shipping 49 49
Patient-Device Incompatibility 47 47
Material Puncture/Hole 47 47
Improper or Incorrect Procedure or Method 47 47
Connection Problem 46 46
Insufficient Information 46 46
Physical Resistance/Sticking 44 44
Material Fragmentation 38 38
Disconnection 37 37
Difficult to Open or Close 37 37
No Flow 37 37
Material Integrity Problem 37 37
Manufacturing, Packaging or Shipping Problem 37 37
Physical Property Issue 36 36
Separation Problem 35 35
Entrapment of Device 34 34
Activation Problem 33 33
Unsealed Device Packaging 32 32
Difficult to Insert 28 28
Partial Blockage 27 27
Device Slipped 27 27
Insufficient Flow or Under Infusion 26 26
Nonstandard Device 26 26
Fail-Safe Design Failure 25 25
Mechanical Jam 25 25
Fitting Problem 23 23
Inadequacy of Device Shape and/or Size 23 23
Tear, Rip or Hole in Device Packaging 22 22
Contamination 22 22
Positioning Failure 22 22
Missing Information 22 22
Incomplete or Inadequate Connection 22 22
Failure To Adhere Or Bond 20 20
Difficult or Delayed Positioning 19 19
Structural Problem 19 19
Malposition of Device 19 19
Inaccurate Delivery 18 18
Incorrect Device Or Component Shipped 18 18
Illegible Information 17 17
Device Or Device Fragments Location Unknown 17 17
Material Discolored 17 17
Fungus in Device Environment 16 16
Incorrect, Inadequate or Imprecise Resultor Readings 16 16
Positioning Problem 16 16
Device Packaging Compromised 16 16
Improper Flow or Infusion 16 16
Device Fell 15 15
Device Difficult to Setup or Prepare 14 14
Sticking 14 14
Loss of or Failure to Bond 14 14
Contamination of Device Ingredient or Reagent 13 13
Device Handling Problem 12 12

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 7352 7352
No Clinical Signs, Symptoms or Conditions 3837 3837
No Consequences Or Impact To Patient 2876 2876
No Patient Involvement 907 907
Needle Stick/Puncture 874 874
No Information 572 572
Foreign Body In Patient 247 247
Hyperglycemia 210 210
Pain 208 208
Insufficient Information 204 204
Exposure to Body Fluids 150 150
Device Embedded In Tissue or Plaque 142 142
No Code Available 110 110
Underdose 71 71
Bruise/Contusion 71 71
Injury 40 40
Hemorrhage/Bleeding 38 38
Hypoglycemia 29 29
Hypersensitivity/Allergic reaction 26 26
Unspecified Infection 25 25
Discomfort 25 25
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 24 24
Missed Dose 23 23
Swelling 21 21
Blood Loss 20 20
Chemical Exposure 18 18
Reaction 17 17
Rash 16 16
Anxiety 15 15
Laceration(s) 14 14
Bacterial Infection 13 13
Reaction, Injection Site 12 12
Skin Inflammation/ Irritation 12 12
Missing Value Reason 11 11
Inflammation 11 11
Irritation 10 10
Nerve Damage 10 10
Burning Sensation 10 10
Overdose 10 10
Visual Impairment 10 10
Diabetic Ketoacidosis 10 10
Skin Tears 9 9
Injection Site Reaction 9 9
Itching Sensation 9 9
Erythema 9 9
Hematoma 8 8
Hypopyon 8 8
Endophthalmitis 8 8
Abscess 8 8
Skin Irritation 7 7
Dizziness 7 7
Patient Problem/Medical Problem 7 7
Not Applicable 6 6
Skin Inflammation 6 6
Swelling/ Edema 6 6
Scarring 6 6
Nausea 5 5
Tissue Damage 5 5
Death 5 5
Infiltration into Tissue 5 5
Vessel Or Plaque, Device Embedded In 4 4
Distress 4 4
Urticaria 4 4
Complaint, Ill-Defined 3 3
Premature Labor 3 3
Miscarriage 3 3
Sepsis 3 3
Cellulitis 3 3
Headache 3 3
Fever 3 3
Extravasation 3 3
Eye Injury 2 2
Fainting 2 2
Fall 2 2
Fatigue 2 2
Hepatitis 2 2
Purulent Discharge 2 2
Air Embolism 2 2
Anaphylactic Shock 2 2
Local Reaction 2 2
Respiratory Distress 2 2
Neuropathy 2 2
Electrolyte Imbalance 2 2
Blurred Vision 2 2
Fungal Infection 2 2
Post Operative Wound Infection 2 2
Malaise 2 2
Test Result 2 2
Abdominal Cramps 2 2
Unspecified Tissue Injury 2 2
Syncope/Fainting 2 2
Unspecified Mental, Emotional or Behavioural Problem 1 1
Ambulation Difficulties 1 1
Inadequate Osseointegration 1 1
Alteration In Body Temperature 1 1
Presyncope 1 1
Numbness 1 1
Loss of consciousness 1 1
Choking 1 1
Palpitations 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 Peripheral Vascular Inc II Oct-01-2021
5 Becton Dickinson & Company II Dec-15-2020
6 Becton Dickinson & Company II Nov-27-2020
7 Becton Dickinson & Company II Aug-27-2020
8 Becton Dickinson & Company II Oct-31-2019
9 Becton Dickinson & Company II Oct-24-2019
10 Becton Dickinson & Company II Jul-22-2019
11 Becton Dickinson & Company II Oct-11-2018
12 Becton Dickinson & Company II Dec-07-2017
13 Becton Dickinson & Company II Sep-11-2017
14 Becton Dickinson & Company II Jul-19-2017
15 C.A. Greiner & Sohne Gesellschaftmbh II Aug-28-2020
16 Cardinal Health 200, LLC II Mar-15-2021
17 Cardinal Health 200, LLC II Nov-05-2020
18 Cardinal Health 200, LLC II Mar-09-2020
19 Cardinal Health 200, LLC II Jul-23-2019
20 Cardinal Health Inc. II Jun-23-2021
21 Centurion Medical Products Corporation II Jan-04-2018
22 Guangzhou Improve Medical Instruments Co., Ltd. II Apr-24-2019
23 Guangzhou Improve Medical Instruments Co., Ltd. II Aug-12-2018
24 Guangzhou Improve Medical Instruments Co., Ltd. II Jul-26-2018
25 International Medsurg Connection, Inc. II Aug-04-2017
26 MHC Medical Products LLC II May-09-2018
27 Owen Mumford USA, Inc. II Jul-15-2021
28 Owen Mumford USA, Inc. II Jan-17-2018
29 Smiths Medical ASD Inc. II Jun-04-2019
30 Smiths Medical ASD Inc. II Jul-03-2017
31 Teleflex Medical II Dec-16-2019
32 Teleflex Medical III Apr-04-2017
33 Terumo Medical Corporation II Jul-22-2019
34 Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. II Feb-21-2018
35 Zhejiang Kindly Medical Devices Co., Ltd. II Nov-05-2021
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