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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
2018 14 14
2019 4 4
2020 2 2
2021 1 1
2022 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Component Missing 6 6
Inaccurate Flow Rate 4 4
Leak/Splash 2 2
Improper or Incorrect Procedure or Method 2 2
Material Twisted/Bent 2 2
No Flow 2 2
Break 2 2
Fluid/Blood Leak 1 1
Gel Leak 1 1
No Device Output 1 1
Use of Device Problem 1 1
Material Split, Cut or Torn 1 1
Misassembled 1 1
Short Fill 1 1
Device Damaged Prior to Use 1 1
Contamination /Decontamination Problem 1 1
Device Markings/Labelling Problem 1 1
Moisture or Humidity Problem 1 1
Component Misassembled 1 1
Material Fragmentation 1 1
Unsealed Device Packaging 1 1
Patient-Device Incompatibility 1 1
Device Operates Differently Than Expected 1 1
Tear, Rip or Hole in Device Packaging 1 1
Device Contamination with Chemical or Other Material 1 1
Material Deformation 1 1
Physical Resistance/Sticking 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 14 14
No Clinical Signs, Symptoms or Conditions 6 6
No Consequences Or Impact To Patient 5 5
No Patient Involvement 5 5
Urinary Tract Infection 3 3
Patient Problem/Medical Problem 3 3
Pulmonary Infarction 1 1
Foreign Body In Patient 1 1
Unspecified Infection 1 1

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