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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
2018 34 34
2019 63 63
2020 22 22
2021 48 48
2022 167 167

Device Problems MDRs with this Device Problem Events in those MDRs
Sharp Edges 92 92
Component Missing 49 49
Material Rupture 23 23
Appropriate Term/Code Not Available 19 19
Break 18 18
Fluid/Blood Leak 15 15
Device Dislodged or Dislocated 14 14
Adverse Event Without Identified Device or Use Problem 13 13
Leak/Splash 12 12
Deflation Problem 9 9
Device Slipped 9 9
Device Fell 9 9
Inflation Problem 8 8
Disconnection 7 7
Detachment of Device or Device Component 7 7
Burst Container or Vessel 6 6
Difficult to Insert 6 6
Product Quality Problem 6 6
Material Twisted/Bent 5 5
Material Integrity Problem 4 4
No Flow 3 3
Patient-Device Incompatibility 3 3
Short Fill 3 3
Complete Blockage 3 3
Entrapment of Device 2 2
Shipping Damage or Problem 2 2
Difficult to Remove 2 2
Nonstandard Device 2 2
Improper or Incorrect Procedure or Method 2 2
Device Contamination with Chemical or Other Material 2 2
Defective Component 2 2
Expiration Date Error 2 2
Output Problem 2 2
Packaging Problem 2 2
Unintended Deflation 2 2
Migration 1 1
Component Misassembled 1 1
Material Too Soft/Flexible 1 1
Material Split, Cut or Torn 1 1
Physical Resistance/Sticking 1 1
Scratched Material 1 1
Therapeutic or Diagnostic Output Failure 1 1
Material Protrusion/Extrusion 1 1
Use of Device Problem 1 1
Material Deformation 1 1
Activation, Positioning or Separation Problem 1 1
Insufficient Flow or Under Infusion 1 1
Fitting Problem 1 1
Device Damaged Prior to Use 1 1
Tear, Rip or Hole in Device Packaging 1 1
Obstruction of Flow 1 1
Structural Problem 1 1
Failure to Advance 1 1
Backflow 1 1
Material Separation 1 1
Unintended Ejection 1 1
Material Disintegration 1 1
Coagulation in Device or Device Ingredient 1 1
Crack 1 1
Inadequate Instructions for Healthcare Professional 1 1
Incorrect Measurement 1 1
Misassembled 1 1
Difficult to Flush 1 1
Flushing Problem 1 1
Fracture 1 1
Material Fragmentation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 66 66
No Clinical Signs, Symptoms or Conditions 65 65
No Known Impact Or Consequence To Patient 50 50
No Consequences Or Impact To Patient 39 39
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 35 35
Unspecified Tissue Injury 33 33
No Patient Involvement 23 23
Urinary Tract Infection 22 22
Insufficient Information 10 10
No Code Available 4 4
Foreign Body In Patient 4 4
Discomfort 4 4
No Information 3 3
Itching Sensation 2 2
Hemorrhage/Bleeding 2 2
Unspecified Infection 1 1
Abrasion 1 1
Bacterial Infection 1 1
Fever 1 1
Respiratory Distress 1 1
Skin Discoloration 1 1
Fungal Infection 1 1
Shaking/Tremors 1 1
Abdominal Distention 1 1
Patient Problem/Medical Problem 1 1
Vaso-Vagal Response 1 1
Tissue Breakdown 1 1
Genital Bleeding 1 1
Skin Inflammation/ Irritation 1 1
Swelling/ Edema 1 1

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