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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device general surgery tray
Definition This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance
Product CodeLRO
Regulation Number 878.4370
Device Class 2


Premarket Reviews
ManufacturerDecision
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2019 406 406
2020 767 767
2021 920 920
2022 1134 1134
2023 1914 1914
2024 176 176

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Cut 1277 1277
Suction Failure 556 556
Fluid/Blood Leak 492 492
Break 365 365
Adverse Event Without Identified Device or Use Problem 292 292
Contamination /Decontamination Problem 200 200
Inability to Irrigate 175 175
Leak/Splash 173 173
Suction Problem 139 139
Detachment of Device or Device Component 120 120
No Flow 113 113
Complete Blockage 110 110
Air/Gas in Device 99 99
Contamination 92 92
Material Twisted/Bent 85 85
Device Contamination with Chemical or Other Material 73 73
Noise, Audible 70 70
Dull, Blunt 66 66
Decrease in Suction 65 65
Material Fragmentation 61 61
Infusion or Flow Problem 49 49
Appropriate Term/Code Not Available 48 48
Particulates 47 47
Product Quality Problem 44 44
Fitting Problem 44 44
Material Puncture/Hole 43 43
Therapeutic or Diagnostic Output Failure 38 38
Loose or Intermittent Connection 37 37
Disconnection 35 35
Component Missing 31 31
Defective Device 30 30
Material Integrity Problem 30 30
Difficult to Remove 30 30
Output Problem 29 29
Obstruction of Flow 29 29
Physical Resistance/Sticking 28 28
Manufacturing, Packaging or Shipping Problem 27 27
Material Separation 25 25
Defective Component 23 23
Device Displays Incorrect Message 20 20
Pressure Problem 20 20
Material Split, Cut or Torn 20 20
Tear, Rip or Hole in Device Packaging 19 19
Gas/Air Leak 19 19
Difficult to Insert 19 19
Failure to Prime 17 17
Crack 17 17
Material Discolored 16 16
Activation, Positioning or Separation Problem 15 15
Failure to Infuse 15 15
Device Damaged Prior to Use 15 15
Mechanics Altered 14 14
Packaging Problem 14 14
Material Too Soft/Flexible 14 14
Difficult to Open or Close 13 13
Delivered as Unsterile Product 13 13
Device Contaminated During Manufacture or Shipping 12 12
Blocked Connection 11 11
Use of Device Problem 11 11
Gas Output Problem 11 11
Nonstandard Device 11 11
Improper Flow or Infusion 10 10
Sharp Edges 10 10
Contamination of Device Ingredient or Reagent 9 9
Material Deformation 9 9
Ambient Noise Problem 8 8
Material Frayed 8 8
Device Fell 8 8
Separation Problem 8 8
Activation Problem 7 7
Mechanical Problem 7 7
Mechanical Jam 7 7
Device Dislodged or Dislocated 6 6
Device Slipped 6 6
No Device Output 6 6
Entrapment of Device 6 6
Fracture 6 6
Loss of or Failure to Bond 6 6
Electrical /Electronic Property Problem 5 5
Reflux within Device 5 5
Energy Output Problem 5 5
Vibration 5 5
Incomplete or Missing Packaging 5 5
Patient-Device Incompatibility 5 5
Failure to Advance 5 5
Connection Problem 5 5
Device Markings/Labelling Problem 4 4
Device Misassembled During Manufacturing /Shipping 4 4
Material Protrusion/Extrusion 4 4
Positioning Problem 4 4
Sparking 4 4
Structural Problem 4 4
Improper or Incorrect Procedure or Method 4 4
Excess Flow or Over-Infusion 4 4
Material Too Rigid or Stiff 4 4
Degraded 4 4
Collapse 4 4
Device Alarm System 4 4
Activation Failure 4 4
No Apparent Adverse Event 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3694 3694
No Consequences Or Impact To Patient 412 412
No Known Impact Or Consequence To Patient 343 343
Insufficient Information 305 305
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 104 104
Endophthalmitis 97 97
Toxic Anterior Segment Syndrome (TASS) 63 63
Foreign Body In Patient 51 51
No Patient Involvement 46 46
Inflammation 45 45
Uveitis 36 36
Capsular Bag Tear 36 36
Unspecified Infection 33 33
Eye Burn 24 24
Corneal Edema 21 21
Retinal Tear 19 19
Intraocular Pressure Decreased 19 19
Eye Pain 15 15
Retinal Detachment 15 15
Hypopyon 15 15
Retinal Injury 13 13
Blurred Vision 13 13
Rupture 12 12
Hemorrhage/Bleeding 12 12
Burn(s) 12 12
Conjunctivitis 12 12
Device Embedded In Tissue or Plaque 11 11
Vitritis 9 9
Visual Impairment 9 9
Loss of Vision 9 9
Intraocular Pressure Increased 9 9
Vitreous Hemorrhage 8 8
Fibrosis 7 7
Unspecified Eye / Vision Problem 7 7
Bacterial Infection 7 7
Foreign Body Sensation in Eye 7 7
Corneal Abrasion 6 6
Pain 6 6
No Code Available 6 6
Injury 5 5
Vitreous Floaters 5 5
Visual Disturbances 5 5
Vitreous Loss 4 4
Red Eye(s) 4 4
Corneal Ulcer 4 4
Eye Injury 4 4
Fluid Discharge 4 4
No Information 3 3
Zonular Dehiscence 3 3
Tissue Damage 3 3
Burn, Thermal 3 3
Air Embolism 3 3
Corneal Clouding/Hazing 3 3
Local Reaction 3 3
Laceration(s) 3 3
Optical Nerve Damage 2 2
Peeling 2 2
Rash 2 2
Itching Sensation 2 2
Keratitis 2 2
Hyperemia 2 2
Hypersensitivity/Allergic reaction 2 2
Hyphema 2 2
Corneal Scar 2 2
Abrasion 2 2
Abscess 2 2
Discomfort 2 2
Vitreous Detachment 2 2
Needle Stick/Puncture 2 2
Prolapse 2 2
Missing Value Reason 2 2
Skin Inflammation/ Irritation 2 2
Skin Tears 2 2
Patient Problem/Medical Problem 1 1
Partial thickness (Second Degree) Burn 1 1
Drug Resistant Bacterial Infection 1 1
Muscle Hypotonia 1 1
Shaking/Tremors 1 1
Post Operative Wound Infection 1 1
Caustic/Chemical Burns 1 1
Chemical Exposure 1 1
Wrinkling 1 1
Vitrectomy 1 1
Superficial (First Degree) Burn 1 1
Wound Dehiscence 1 1
Abdominal Pain 1 1
Calcium Deposits/Calcification 1 1
Stroke/CVA 1 1
Chemosis 1 1
Crushing Injury 1 1
Death 1 1
Purulent Discharge 1 1
Edema 1 1
Exposure to Body Fluids 1 1
Bowel Burn 1 1
Erythema 1 1
Bone Fracture(s) 1 1
Failure of Implant 1 1
Hematoma 1 1
Hemolysis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Alcon Research, LLC II Nov-07-2023
2 Alcon Research, LLC II Mar-28-2023
3 Alcon Research, LLC II Dec-01-2022
4 Alcon Research, LLC II Jul-12-2022
5 Alcon Research, LLC II Apr-01-2021
6 Alcon Research, LLC II Oct-09-2020
7 American Contract Systems II May-29-2020
8 American Contract Systems, Inc. II Jan-26-2024
9 American Contract Systems, Inc. II Oct-26-2023
10 American Contract Systems, Inc. II Nov-22-2022
11 American Contract Systems, Inc. II Sep-08-2022
12 Avid Medical, Inc. I Jun-04-2021
13 Avid Medical, Inc. II Mar-19-2020
14 Cardinal Health 200, LLC II Oct-10-2023
15 Cardinal Health 200, LLC II Feb-04-2020
16 Cardinal Health 200, LLC II Feb-03-2020
17 Cardinal Health Inc. II Jan-09-2019
18 Centurion Medical Products Corporation II Feb-05-2020
19 Centurion Medical Products Corporation II Nov-06-2019
20 Centurion Medical Products Corporation II Oct-31-2019
21 Custom Healthcare Systems, Inc. II Jan-24-2020
22 DeRoyal Industries Inc II Oct-16-2023
23 DeRoyal Industries Inc II Jul-03-2023
24 DeRoyal Industries Inc II Jun-07-2023
25 DeRoyal Industries Inc II Jan-09-2023
26 DeRoyal Industries Inc II Jan-05-2023
27 DeRoyal Industries Inc II Dec-15-2022
28 DeRoyal Industries Inc II Aug-31-2022
29 DeRoyal Industries Inc II Apr-06-2022
30 DeRoyal Industries Inc I Jun-10-2021
31 DeRoyal Industries Inc II Feb-19-2021
32 DeRoyal Industries Inc II Jul-16-2019
33 Deroyal Industries, Inc. Lafollette I Sep-29-2021
34 Deroyal Industries, Inc. Lafollette II Feb-19-2020
35 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
36 MEDLINE INDUSTRIES, LP - Northfield I Dec-22-2023
37 MEDLINE INDUSTRIES, LP - Northfield II Dec-11-2023
38 MEDLINE INDUSTRIES, LP - Northfield II Nov-16-2023
39 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
40 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
41 MEDLINE INDUSTRIES, LP - Northfield II Jul-12-2023
42 MEDLINE INDUSTRIES, LP - Northfield II Feb-23-2023
43 MEDLINE INDUSTRIES, LP - Northfield II Feb-10-2023
44 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
45 MEDLINE INDUSTRIES, LP - Northfield II Jan-27-2023
46 MEDLINE INDUSTRIES, LP - Northfield II Nov-01-2022
47 MEDLINE INDUSTRIES, LP - Northfield II Oct-21-2022
48 MEDLINE INDUSTRIES, LP - Northfield II Oct-20-2022
49 MEDLINE INDUSTRIES, LP - SPT II Jul-27-2022
50 Medical Action Industries, Inc. 306 II Jun-24-2021
51 Medline Industries Inc II Dec-10-2021
52 Medline Industries Inc II Jun-09-2021
53 Medline Industries Inc II Jan-07-2021
54 Medline Industries Inc II May-15-2020
55 Medline Industries Inc II Mar-20-2020
56 ROi CPS LLC I Jan-12-2024
57 ROi CPS LLC II Apr-25-2023
58 ROi CPS LLC II Nov-23-2022
59 ROi CPS LLC II Jun-09-2022
60 ROi CPS LLC II Nov-18-2021
61 ROi CPS LLC II Jan-30-2020
62 Stradis Medical, LLC dba Stradis Healthcare II Dec-14-2022
63 Stryker GmbH II Mar-06-2019
64 Wright Medical Technology, Inc. II Aug-13-2020
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