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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device clamp
Product CodeHXD
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2019 125 125
2020 114 114
2021 75 75
2022 88 88
2023 99 99
2024 39 39

Device Problems MDRs with this Device Problem Events in those MDRs
Device-Device Incompatibility 251 251
Break 129 129
Mechanical Jam 55 55
Structural Problem 39 39
Naturally Worn 34 34
Physical Resistance/Sticking 20 20
Mechanical Problem 18 18
Detachment of Device or Device Component 16 16
Material Twisted/Bent 16 16
Component Missing 15 15
Crack 15 15
Difficult to Open or Close 13 13
Material Deformation 12 12
Fracture 11 11
Unintended Movement 9 9
Appropriate Term/Code Not Available 7 7
Material Integrity Problem 6 6
Fitting Problem 6 6
Device Slipped 4 4
Illegible Information 4 4
Use of Device Problem 3 3
Entrapment of Device 3 3
Positioning Failure 2 2
Difficult to Remove 2 2
Connection Problem 2 2
Separation Problem 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Positioning Problem 2 2
Scratched Material 2 2
No Apparent Adverse Event 1 1
Insufficient Flow or Under Infusion 1 1
Device Damaged Prior to Use 1 1
Contamination /Decontamination Problem 1 1
Material Disintegration 1 1
Fluid/Blood Leak 1 1
Loose or Intermittent Connection 1 1
Incorrect Measurement 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 290 290
No Consequences Or Impact To Patient 200 200
No Code Available 27 27
Insufficient Information 20 20
Not Applicable 14 14
No Known Impact Or Consequence To Patient 5 5
Patient Problem/Medical Problem 3 3
No Patient Involvement 3 3
Hemorrhage/Bleeding 3 3
Hyperglycemia 1 1
Failure of Implant 1 1
Foreign Body In Patient 1 1
Device Embedded In Tissue or Plaque 1 1
Skin Inflammation/ Irritation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 MEDLINE INDUSTRIES, LP - Northfield II Mar-29-2024
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