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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
2014 1 1
2015 11 11
2016 25 25
2017 25 25
2018 34 34
2019 63 63
2020 22 22
2021 48 48
2022 167 167
2023 144 144
2024 66 66

Device Problems MDRs with this Device Problem Events in those MDRs
Sharp Edges 92 92
Component Missing 57 57
Material Integrity Problem 56 56
Appropriate Term/Code Not Available 54 54
Break 40 40
Fluid/Blood Leak 40 40
Leak/Splash 32 32
Material Rupture 27 27
Deflation Problem 21 21
Burst Container or Vessel 18 18
Adverse Event Without Identified Device or Use Problem 15 15
Device Dislodged or Dislocated 15 15
Inflation Problem 14 14
Detachment of Device or Device Component 12 12
Device Slipped 10 10
Device Fell 9 9
Product Quality Problem 8 8
Kinked 7 7
Disconnection 7 7
Difficult to Insert 6 6
Detachment Of Device Component 5 5
Material Twisted/Bent 5 5
Insufficient Information 5 5
Material Split, Cut or Torn 4 4
Packaging Problem 4 4
No Flow 4 4
Folded 4 4
Connection Problem 4 4
Material Fragmentation 4 4
Material Separation 3 3
Nonstandard Device 3 3
Component Falling 3 3
Complete Blockage 3 3
Patient-Device Incompatibility 3 3
Device Contamination with Chemical or Other Material 3 3
Output Problem 3 3
Infusion or Flow Problem 3 3
Material Puncture/Hole 3 3
Short Fill 3 3
Defective Component 3 3
Obstruction of Flow 3 3
Expiration Date Error 2 2
Physical Resistance 2 2
Device Damaged Prior to Use 2 2
Use of Device Problem 2 2
Improper or Incorrect Procedure or Method 2 2
Device Operates Differently Than Expected 2 2
No Device Output 2 2
Incorrect Measurement 2 2
Shipping Damage or Problem 2 2
Difficult to Remove 2 2
Entrapment of Device 2 2
Tear, Rip or Hole in Device Packaging 2 2
No Apparent Adverse Event 2 2
Component Misassembled 2 2
Unintended Deflation 2 2
Wrong Label 1 1
Failure to Deflate 1 1
Material Too Soft/Flexible 1 1
Physical Resistance/Sticking 1 1
Migration 1 1
Positioning Problem 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
Inadequate Instructions for Healthcare Professional 1 1
Loose or Intermittent Connection 1 1
Mechanical Problem 1 1
Misassembled 1 1
Coagulation in Device or Device Ingredient 1 1
Contamination 1 1
Crack 1 1
Material Disintegration 1 1
Bent 1 1
Backflow 1 1
Difficult to Flush 1 1
Flushing Problem 1 1
Fracture 1 1
Difficult to Advance 1 1
Improper Device Output 1 1
Activation, Positioning or Separation Problem 1 1
Material Deformation 1 1
Material Protrusion/Extrusion 1 1
Insufficient Flow or Under Infusion 1 1
Fitting Problem 1 1
Device Inoperable 1 1
Out-Of-Box Failure 1 1
Device Issue 1 1
Structural Problem 1 1
Failure to Advance 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 170 170
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 102 102
No Known Impact Or Consequence To Patient 75 75
Pain 67 67
No Consequences Or Impact To Patient 54 54
Unspecified Tissue Injury 33 33
Urinary Tract Infection 29 29
Insufficient Information 28 28
No Patient Involvement 26 26
Foreign Body In Patient 12 12
No Information 8 8
Discomfort 6 6
Urinary Incontinence 5 5
No Code Available 4 4
Urinary Retention 4 4
Hemorrhage/Bleeding 4 4
Unspecified Infection 2 2
Itching Sensation 2 2
Hematuria 2 2
Swelling/ Edema 2 2
Patient Problem/Medical Problem 1 1
Blood Loss 1 1
Abdominal Distention 1 1
Vaso-Vagal Response 1 1
Tissue Breakdown 1 1
Genital Bleeding 1 1
Skin Inflammation/ Irritation 1 1
Respiratory Distress 1 1
Skin Discoloration 1 1
Fungal Infection 1 1
Shaking/Tremors 1 1
Inflammation 1 1
Incontinence 1 1
Abrasion 1 1
Bacterial Infection 1 1
Exposure to Body Fluids 1 1
Fever 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Apogee Medical, Inc II May-03-2011
2 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
3 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
4 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
5 Medical Device Technologies, Inc. II Nov-18-2011
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