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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device collector, urine, pediatric, for indwelling catheter
Product CodeFFH
Regulation Number 876.5250
Device Class 2

MDR Year MDR Reports MDR Events
2015 5 5
2017 8 8
2018 14 14
2019 4 4
2020 2 2
2021 1 1
2022 5 5
2023 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Component Missing 6 6
No Flow 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Disconnection 4 4
Inaccurate Flow Rate 4 4
Material Fragmentation 3 3
Hole In Material 3 3
Leak/Splash 3 3
Difficult to Remove 3 3
Fitting Problem 3 3
Break 2 2
Component Misassembled 2 2
Material Twisted/Bent 2 2
Improper or Incorrect Procedure or Method 2 2
Moisture or Humidity Problem 1 1
Material Split, Cut or Torn 1 1
Physical Resistance/Sticking 1 1
Tear, Rip or Hole in Device Packaging 1 1
Defective Device 1 1
Patient-Device Incompatibility 1 1
Contamination /Decontamination Problem 1 1
Contamination of Device Ingredient or Reagent 1 1
Device Markings/Labelling Problem 1 1
Device Operates Differently Than Expected 1 1
Difficult to Open or Remove Packaging Material 1 1
Device Contamination with Chemical or Other Material 1 1
Material Deformation 1 1
Material Integrity Problem 1 1
Bent 1 1
Fluid/Blood Leak 1 1
Kinked 1 1
Gel Leak 1 1
Device Damaged Prior to Use 1 1
Short Fill 1 1
Use of Device Problem 1 1
Loose or Intermittent Connection 1 1
Misassembled 1 1
No Device Output 1 1
Unsealed Device Packaging 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 19 19
No Clinical Signs, Symptoms or Conditions 15 15
No Consequences Or Impact To Patient 6 6
No Patient Involvement 5 5
Unspecified Infection 5 5
Urinary Tract Infection 3 3
Patient Problem/Medical Problem 3 3
Foreign Body In Patient 2 2
No Information 2 2
Insufficient Information 2 2
Bacterial Infection 1 1
Pulmonary Infarction 1 1

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