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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 105 105

Device Problems MDRs with this Device Problem Events in those MDRs
Sharp Edges 92 92
Appropriate Term/Code Not Available 61 61
Material Integrity Problem 60 60
Component Missing 43 43
Fluid/Blood Leak 35 35
Leak/Splash 31 31
Break 28 28
Material Rupture 26 26
Burst Container or Vessel 18 18
Inflation Problem 17 17
Device Dislodged or Dislocated 13 13
Adverse Event Without Identified Device or Use Problem 13 13
Detachment of Device or Device Component 12 12
Deflation Problem 11 11
Device Slipped 9 9
Disconnection 7 7
Device Fell 7 7
Insufficient Information 5 5
Difficult to Insert 5 5
Material Twisted/Bent 5 5
Material Split, Cut or Torn 4 4
Connection Problem 4 4
Material Puncture/Hole 4 4
Material Fragmentation 4 4
Obstruction of Flow 4 4
Output Problem 3 3
Nonstandard Device 3 3
Component Misassembled 3 3
Short Fill 3 3
Product Quality Problem 3 3
Infusion or Flow Problem 3 3
No Flow 2 2
Improper or Incorrect Procedure or Method 2 2
Failure to Deflate 2 2
No Apparent Adverse Event 2 2
Device Contamination with Chemical or Other Material 2 2
Tear, Rip or Hole in Device Packaging 2 2
Material Separation 2 2
Incorrect Measurement 2 2
Packaging Problem 2 2
Shipping Damage or Problem 2 2
Difficult to Remove 2 2
Expiration Date Error 2 2
Defective Component 2 2
Unintended Deflation 2 2
Crack 2 2
Entrapment of Device 2 2
Inaccurate Flow Rate 1 1
Insufficient Flow or Under Infusion 1 1
Structural Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 200 200
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 103 103
Pain 69 69
No Known Impact Or Consequence To Patient 36 36
Unspecified Tissue Injury 33 33
Insufficient Information 32 32
No Consequences Or Impact To Patient 28 28
Urinary Tract Infection 22 22
No Patient Involvement 20 20
Foreign Body In Patient 9 9
Urinary Incontinence 5 5
Discomfort 4 4
No Code Available 3 3
Unspecified Infection 2 2
No Information 2 2
Urinary Retention 2 2
Swelling/ Edema 2 2
Hemorrhage/Bleeding 2 2
Patient Problem/Medical Problem 1 1
Fungal Infection 1 1
Genital Bleeding 1 1
Skin Inflammation/ Irritation 1 1
Abrasion 1 1
Itching Sensation 1 1
Incontinence 1 1
Skin Discoloration 1 1
Fever 1 1
Exposure to Body Fluids 1 1
Bacterial Infection 1 1
Tissue Breakdown 1 1

Recalls
Manufacturer Recall Class Date Posted
1 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
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
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