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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
Regulation Description Surgical drape and drape accessories.
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 1

MDR Year MDR Reports MDR Events
2017 523 523
2018 384 384
2019 406 406
2020 767 767
2021 915 915

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 451 451
Failure to Cut 381 381
Fluid Leak 309 309
Break 192 192
Adverse Event Without Identified Device or Use Problem 180 180
Contamination /Decontamination Problem 138 138
Device Contamination with Chemical or Other Material 119 119
Suction Failure 86 86
Detachment of Device or Device Component 79 79
Material Fragmentation 72 72
Suction Problem 57 57
Dull, Blunt 49 49
Contamination 43 43
Air/Gas in Device 38 38
Therapeutic or Diagnostic Output Failure 38 38
Material Integrity Problem 37 37
Inability to Irrigate 32 32
Material Puncture/Hole 31 31
Component Missing 30 30
Detachment Of Device Component 28 28
Noise, Audible 26 26
Physical Resistance/Sticking 26 26
Output Problem 24 24
Loose or Intermittent Connection 24 24
Obstruction of Flow 24 24
Device Operates Differently Than Expected 24 24
Manufacturing, Packaging or Shipping Problem 23 23
Infusion or Flow Problem 22 22
Difficult to Insert 22 22
Material Separation 21 21
Material Discolored 20 20
Insufficient Information 19 19
Decrease in Suction 18 18
Appropriate Term/Code Not Available 17 17
Pressure Problem 16 16
Complete Blockage 16 16
Difficult to Remove 16 16
No Flow 16 16
Defective Device 16 16
Fitting Problem 15 15
Gas Leak 15 15
Contamination of Device Ingredient or Reagent 15 15
Activation, Positioning or SeparationProblem 15 15
Mechanics Altered 14 14
Material Frayed 14 14
Material Too Soft/Flexible 14 14
Material Split, Cut or Torn 14 14
Particulates 13 13
Device Contaminated During Manufacture or Shipping 13 13
Tear, Rip or Hole in Device Packaging 13 13
Material Twisted/Bent 12 12
Patient-Device Incompatibility 12 12
Device Dislodged or Dislocated 12 12
Product Quality Problem 12 12
Mechanical Problem 12 12
Delivered as Unsterile Product 11 11
Entrapment of Device 11 11
Difficult to Open or Close 10 10
Device Displays Incorrect Message 10 10
Device Slipped 9 9
Use of Device Problem 9 9
Nonstandard Device 9 9
Sticking 8 8
Mechanical Jam 8 8
Material Deformation 8 8
Device Fell 8 8
Activation Problem 7 7
Packaging Problem 7 7
Fire 7 7
Hole In Material 7 7
Disconnection 7 7
Crack 7 7
Material Too Rigid or Stiff 7 7
Material Disintegration 6 6
Device Damaged Prior to Use 6 6
Positioning Problem 6 6
Separation Problem 5 5
Defective Component 5 5
Failure to Advance 5 5
Improper Flow or Infusion 5 5
Device Packaging Compromised 5 5
Reflux within Device 5 5
Kinked 5 5
No Device Output 4 4
Degraded 4 4
Electrical /Electronic Property Problem 4 4
Collapse 4 4
Component Falling 4 4
Loss of or Failure to Bond 4 4
Device Misassembled During Manufacturing /Shipping 4 4
Device Contamination With Biological Material 4 4
Sparking 4 4
Structural Problem 4 4
Improper or Incorrect Procedure or Method 4 4
Temperature Problem 4 4
Unintended Movement 4 4
Activation Failure 3 3
Physical Property Issue 3 3
Failure to Infuse 3 3
Device Or Device Fragments Location Unknown 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 926 926
No Known Impact Or Consequence To Patient 855 855
No Consequences Or Impact To Patient 617 617
Insufficient Information 108 108
Foreign Body In Patient 66 66
No Patient Involvement 65 65
No Information 42 42
Unspecified Infection 39 39
Inflammation 37 37
Endophthalmitis 34 34
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 32 32
Toxic Anterior Segment Syndrome (TASS) 27 27
No Code Available 27 27
Device Embedded In Tissue or Plaque 22 22
Uveitis 22 22
Capsular Bag Tear 13 13
Hemorrhage/Bleeding 12 12
Corneal Edema 10 10
Retinal Tear 10 10
Rash 9 9
Vitritis 9 9
Burn(s) 9 9
Eye Burn 8 8
Hypopyon 7 7
Injury 7 7
Loss of Vision 7 7
Retinal Detachment 6 6
Eye Injury 6 6
Blurred Vision 5 5
Skin Tears 4 4
Complaint, Ill-Defined 4 4
Laceration(s) 4 4
Tissue Damage 4 4
Conjunctivitis 4 4
Abrasion 4 4
Bacterial Infection 4 4
Itching Sensation 4 4
Corneal Clouding/Hazing 4 4
Eye Pain 4 4
Intraocular Pressure Decreased 4 4
Fluid Discharge 4 4
Burn, Thermal 3 3
Fibrosis 3 3
Intraocular Pressure Increased 3 3
Pain 3 3
Local Reaction 3 3
Optical Nerve Damage 2 2
Thrombus 2 2
Sepsis 2 2
Reaction 2 2
Visual Impairment 2 2
Vitreous Loss 2 2
Vitreous Hemorrhage 2 2
Hyphema 2 2
Bone Fracture(s) 2 2
Abscess 2 2
Death 2 2
Zonular Dehiscence 2 2
Missing Value Reason 2 2
Unspecified Eye / Vision Problem 2 2
Muscle Hypotonia 1 1
Drug Resistant Bacterial Infection 1 1
Multiple Organ Failure 1 1
Caustic/Chemical Burns 1 1
Vitrectomy 1 1
Superficial (First Degree) Burn 1 1
Patient Problem/Medical Problem 1 1
Purulent Discharge 1 1
Edema 1 1
Corneal Scar 1 1
Corneal Ulcer 1 1
Vitreous Floaters 1 1
Foreign Body Sensation in Eye 1 1
Erythema 1 1
Exposure to Body Fluids 1 1
Bowel Burn 1 1
Corneal Abrasion 1 1
Stroke/CVA 1 1
Chemosis 1 1
Abdominal Pain 1 1
Hematoma 1 1
Hemolysis 1 1
Hemorrhage, Cerebral 1 1
Hyperemia 1 1
Hypersensitivity/Allergic reaction 1 1
High Blood Pressure/ Hypertension 1 1
Keratitis 1 1
Low Blood Pressure/ Hypotension 1 1
Failure of Implant 1 1
Intraocular Pressure, Delayed, Uncontrolled 1 1
Rupture 1 1
Cardiac Tamponade 1 1
Distress 1 1
Discomfort 1 1
Loss of consciousness 1 1
Vitreous Detachment 1 1
Post Operative Wound Infection 1 1
Needle Stick/Puncture 1 1
Prolapse 1 1
Toxicity 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Alcon Research, LLC II Apr-01-2021
2 Alcon Research, LLC II Oct-09-2020
3 Alcon Research, LTD. II Aug-25-2017
4 American Contract Systems II May-29-2020
5 Avid Medical, Inc. I Jun-04-2021
6 Avid Medical, Inc. II Mar-19-2020
7 Avid Medical, Inc. II Feb-28-2018
8 Avid Medical, Inc. II Feb-09-2018
9 Cardinal Health 200, LLC II Feb-04-2020
10 Cardinal Health 200, LLC II Feb-03-2020
11 Cardinal Health 200, LLC II Aug-14-2017
12 Cardinal Health Inc. II Jan-09-2019
13 Centurion Medical Products Corporation II Feb-05-2020
14 Centurion Medical Products Corporation II Nov-06-2019
15 Centurion Medical Products Corporation II Oct-31-2019
16 Custom Assemblies Inc II Aug-22-2017
17 Custom Healthcare Systems, Inc. II Jan-24-2020
18 Custom Healthcare Systems, Inc. II Oct-25-2018
19 DeRoyal Industries Inc I Jun-10-2021
20 DeRoyal Industries Inc II Feb-19-2021
21 DeRoyal Industries Inc II Jul-16-2019
22 DeRoyal Industries Inc II Feb-16-2018
23 DeRoyal Industries Inc II Jan-12-2018
24 DeRoyal Industries Inc II Dec-06-2017
25 DeRoyal Industries Inc III Feb-23-2017
26 Deroyal Industries, Inc. Lafollette I Sep-29-2021
27 Deroyal Industries, Inc. Lafollette II Feb-19-2020
28 Encore Medical, Lp II Aug-02-2018
29 Medical Action Industries, Inc. 306 II Jun-24-2021
30 Medline Industries Inc II Dec-10-2021
31 Medline Industries Inc II Jun-09-2021
32 Medline Industries Inc II Jan-07-2021
33 Medline Industries Inc II May-15-2020
34 Medline Industries Inc II Mar-20-2020
35 ROi CPS LLC II Nov-18-2021
36 ROi CPS LLC II Jan-30-2020
37 Resource Optimization & Innovation Llc II Nov-21-2017
38 Resource Optimization & Innovation Llc II Mar-24-2017
39 Stryker GmbH II Mar-06-2019
40 Windstone Medical Packaging, Inc. II Nov-07-2017
41 Wright Medical Technology, Inc. II Aug-13-2020
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