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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device urinometer, electrical
Product CodeEXS
Regulation Number 876.1800
Device Class 2

MDR Year MDR Reports MDR Events
2017 29 29
2018 16 16
2019 18 18
2020 13 13
2021 33 33
2022 226 226
2023 97 97
2024 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Volume Accuracy Problem 99 99
Device Sensing Problem 88 88
Display or Visual Feedback Problem 50 50
Component Misassembled 33 33
Computer Software Problem 32 32
Operating System Becomes Nonfunctional 24 24
Incorrect, Inadequate or Imprecise Result or Readings 21 21
Restricted Flow rate 20 20
Erratic or Intermittent Display 13 13
Computer Operating System Problem 12 12
Break 12 12
Circuit Failure 10 10
Incorrect Measurement 10 10
Failure to Calibrate 10 10
Use of Device Problem 7 7
Material Fragmentation 7 7
Intermittent Loss of Power 7 7
Defective Component 6 6
Failure to Power Up 5 5
Unable to Obtain Readings 5 5
Inadequate or Insufficient Training 5 5
Device Handling Problem 4 4
Improper Flow or Infusion 4 4
Component Missing 4 4
Defective Device 4 4
Device Displays Incorrect Message 4 4
Device Operates Differently Than Expected 4 4
Fitting Problem 3 3
Failure to Sense 3 3
Inaccurate Flow Rate 3 3
Material Protrusion/Extrusion 3 3
Application Interface Becomes Non-Functional Or Program Exits Abnormally 2 2
Data Problem 2 2
Calibration Problem 2 2
Incorrect Or Inadequate Test Results 2 2
Material Twisted/Bent 2 2
Temperature Problem 2 2
Overheating of Device 2 2
Nonstandard Device 2 2
Device Dislodged or Dislocated 2 2
Therapeutic or Diagnostic Output Failure 2 2
Device Alarm System 2 2
Device Markings/Labelling Problem 2 2
Output Problem 2 2
Improper Device Output 2 2
Appropriate Term/Code Not Available 1 1
Labelling, Instructions for Use or Training Problem 1 1
Detachment of Device or Device Component 1 1
Misassembly During Maintenance/Repair 1 1
Battery Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 271 271
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 104 104
No Known Impact Or Consequence To Patient 55 55
No Patient Involvement 21 21
No Consequences Or Impact To Patient 21 21
No Information 12 12
Insufficient Information 4 4
Cramp(s) /Muscle Spasm(s) 1 1

Recalls
Manufacturer Recall Class Date Posted
1 C.R. Bard Inc II Dec-14-2023
2 C.R. Bard Inc II Jun-27-2022
3 C.R. Bard, Inc. II Jun-15-2018
4 C.R. Bard, Inc. II Feb-09-2018
5 C.R. Bard, Inc. II Jan-29-2018
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