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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
Break 12 12
Computer Operating System Problem 12 12
Failure to Calibrate 10 10
Incorrect Measurement 10 10
Circuit Failure 10 10
Material Fragmentation 7 7
Use of Device Problem 7 7
Intermittent Loss of Power 7 7
Defective Component 6 6
Unable to Obtain Readings 5 5
Failure to Power Up 5 5
Inadequate or Insufficient Training 5 5
Device Operates Differently Than Expected 4 4
Defective Device 4 4
Device Handling Problem 4 4
Component Missing 4 4
Improper Flow or Infusion 4 4
Device Displays Incorrect Message 4 4
Fitting Problem 3 3
Inaccurate Flow Rate 3 3
Failure to Sense 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
Overheating of Device 2 2
Improper Device Output 2 2
Output Problem 2 2
Nonstandard Device 2 2
Material Twisted/Bent 2 2
Incorrect Or Inadequate Test Results 2 2
Therapeutic or Diagnostic Output Failure 2 2
Device Dislodged or Dislocated 2 2
Temperature Problem 2 2
Device Alarm System 2 2
Device Markings/Labelling Problem 2 2
Loose or Intermittent Connection 1 1
Device Inoperable 1 1
Electrical /Electronic Property Problem 1 1
No Device Output 1 1
Appropriate Term/Code Not Available 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
6 C.R. Bard, Inc., Urological Division III Dec-21-2010
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