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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter care 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 CodeOHR
Regulation Number 876.5130
Device Class 2

MDR Year MDR Reports MDR Events
2019 63 63
2020 22 22
2021 48 48
2022 167 167
2023 144 144
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Sharp Edges 92 92
Material Integrity Problem 48 48
Component Missing 41 41
Appropriate Term/Code Not Available 36 36
Fluid/Blood Leak 31 31
Material Rupture 25 25
Break 24 24
Burst Container or Vessel 18 18
Leak/Splash 18 18
Device Dislodged or Dislocated 13 13
Adverse Event Without Identified Device or Use Problem 13 13
Detachment of Device or Device Component 12 12
Device Slipped 9 9
Inflation Problem 8 8
Disconnection 7 7
Device Fell 7 7
Deflation Problem 6 6
Difficult to Insert 5 5
Material Twisted/Bent 5 5
Material Split, Cut or Torn 4 4
Output Problem 3 3
Nonstandard Device 3 3
Material Puncture/Hole 3 3
Product Quality Problem 3 3
Difficult to Remove 2 2
Incorrect Measurement 2 2
Improper or Incorrect Procedure or Method 2 2
Shipping Damage or Problem 2 2
Short Fill 2 2
Material Fragmentation 2 2
Defective Component 2 2
Entrapment of Device 2 2
Packaging Problem 2 2
Infusion or Flow Problem 2 2
Expiration Date Error 2 2
Connection Problem 2 2
Tear, Rip or Hole in Device Packaging 2 2
Unintended Deflation 2 2
No Flow 2 2
No Apparent Adverse Event 2 2
Insufficient Information 2 2
Component Misassembled 2 2
Material Too Soft/Flexible 1 1
Migration 1 1
Physical Resistance/Sticking 1 1
Failure to Deflate 1 1
Obstruction of Flow 1 1
Structural Problem 1 1
Activation, Positioning or Separation Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Material Deformation 1 1
Material Protrusion/Extrusion 1 1
Scratched Material 1 1
Therapeutic or Diagnostic Output Failure 1 1
Unintended Movement 1 1
Unintended Ejection 1 1
Inaccurate Flow Rate 1 1
Flushing Problem 1 1
Fracture 1 1
Inadequate Instructions for Healthcare Professional 1 1
Loose or Intermittent Connection 1 1
Backflow 1 1
Material Disintegration 1 1
Coagulation in Device or Device Ingredient 1 1
Crack 1 1
Insufficient Flow or Under Infusion 1 1
Fitting Problem 1 1
Device Damaged Prior to Use 1 1
Mechanical Problem 1 1
Material Separation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 134 134
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 90 90
Pain 66 66
No Known Impact Or Consequence To Patient 36 36
Unspecified Tissue Injury 33 33
No Consequences Or Impact To Patient 28 28
Insufficient Information 22 22
Urinary Tract Infection 20 20
No Patient Involvement 20 20
Foreign Body In Patient 8 8
Discomfort 4 4
No Code Available 3 3
Hemorrhage/Bleeding 2 2
Swelling/ Edema 2 2
No Information 2 2
Bacterial Infection 1 1
Patient Problem/Medical Problem 1 1
Skin Inflammation/ Irritation 1 1
Itching Sensation 1 1
Unspecified Infection 1 1
Fungal Infection 1 1
Fever 1 1
Urinary Retention 1 1
Abrasion 1 1
Tissue Breakdown 1 1
Exposure to Body Fluids 1 1
Genital Bleeding 1 1
Skin Discoloration 1 1

Recalls
Manufacturer Recall Class Date Posted
1 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
2 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
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