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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device tray, surgical
Product CodeLRP
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2018 8 8
2019 6 6
2020 5 5
2021 3 3
2022 10 10
2023 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Break 10 10
Appropriate Term/Code Not Available 4 4
Component Missing 2 2
Contamination /Decontamination Problem 2 2
Unraveled Material 2 2
Device Dislodged or Dislocated 2 2
Device Contamination with Chemical or Other Material 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Material Deformation 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Output Problem 1 1
Insufficient Information 1 1
Device Contaminated During Manufacture or Shipping 1 1
Device Damaged Prior to Use 1 1
Defective Component 1 1
Detachment of Device or Device Component 1 1
Device Contamination With Biological Material 1 1
Device Damaged by Another Device 1 1
Difficult to Open or Remove Packaging Material 1 1
Crack 1 1
Fire 1 1
Difficult to Insert 1 1
Retraction Problem 1 1
Material Separation 1 1
Sharp Edges 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 11 11
No Known Impact Or Consequence To Patient 8 8
Foreign Body In Patient 6 6
Insufficient Information 4 4
No Patient Involvement 4 4
Needle Stick/Puncture 2 2
No Information 2 2
Cerebrospinal Fluid Leakage 1 1
Unspecified Infection 1 1
Laceration(s) 1 1
No Consequences Or Impact To Patient 1 1
Rupture 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cardinal Health 200, LLC II Sep-25-2020
2 Cardinal Health 200, LLC II Jul-18-2018
3 Centurion Medical Products Corporation II Feb-05-2020
4 Centurion Medical Products Corporation II Oct-31-2019
5 Centurion Medical Products Corporation II Oct-09-2019
6 Centurion Medical Products Corporation II Aug-06-2019
7 Centurion Medical Products Corporation II Mar-17-2018
8 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
9 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
10 MEDLINE INDUSTRIES, LP - Northfield II Feb-10-2023
11 MEDLINE INDUSTRIES, LP - Northfield II Nov-01-2022
12 Medline Industries Inc II Jan-25-2020
13 Medline Industries Inc. II Sep-07-2022
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