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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device bag, urine collection, leg, for external use, sterile
Product CodeFAQ
Regulation Number 876.5250
Device Class 1

MDR Year MDR Reports MDR Events
2014 4 4
2015 1 1
2016 13 13
2017 22 22
2018 3 3
2019 3 3
2020 1 1
2021 70 70
2022 48 48
2023 36 36
2024 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Restricted Flow rate 86 86
Component Missing 28 28
Biocompatibility 15 15
Deformation Due to Compressive Stress 8 8
Fluid/Blood Leak 8 8
No Flow 8 8
Adverse Event Without Identified Device or Use Problem 7 7
Component Misassembled 6 6
Material Twisted/Bent 5 5
Obstruction of Flow 5 5
Kinked 4 4
Nonstandard Device 3 3
Patient-Device Incompatibility 3 3
Device Operates Differently Than Expected 3 3
Partial Blockage 3 3
Disconnection 3 3
Material Rupture 3 3
Physical Resistance/Sticking 3 3
No Apparent Adverse Event 2 2
Insufficient Information 2 2
Improper Flow or Infusion 2 2
Infusion or Flow Problem 2 2
Complete Blockage 2 2
Inadequate Instructions for Healthcare Professional 2 2
Leak/Splash 2 2
Incorrect Measurement 1 1
Inaccurate Flow Rate 1 1
Occlusion Within Device 1 1
Fungus in Device Environment 1 1
Tear, Rip or Hole in Device Packaging 1 1
Folded 1 1
Difficult to Open or Close 1 1
Device Contamination with Chemical or Other Material 1 1
Detachment of Device or Device Component 1 1
Collapse 1 1
Filling Problem 1 1
Hole In Material 1 1
Inflation Problem 1 1
Labelling, Instructions for Use or Training Problem 1 1
Material Separation 1 1
Failure To Service 1 1
Sticking 1 1
Unexpected Therapeutic Results 1 1
Inadequate or Insufficient Training 1 1
Device Inoperable 1 1
Defective Component 1 1
Microbial Contamination of Device 1 1
Device Contaminated During Manufacture or Shipping 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Device Handling Problem 1 1
Illegible Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 124 124
Urinary Tract Infection 26 26
No Known Impact Or Consequence To Patient 25 25
No Consequences Or Impact To Patient 10 10
Sepsis 8 8
No Information 5 5
Discomfort 5 5
Urinary Retention 5 5
No Patient Involvement 3 3
Unspecified Infection 3 3
Insufficient Information 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Skin Irritation 1 1
No Code Available 1 1
Skin Inflammation/ Irritation 1 1
Rash 1 1
Bacterial Infection 1 1
Burn(s) 1 1
Patient Problem/Medical Problem 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Teleflex Medical II Jun-27-2011
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