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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
2019 6 6
2020 5 5
2021 3 3
2022 10 10
2023 8 8
2024 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Break 12 12
Leak/Splash 3 3
Peeled/Delaminated 2 2
Unraveled Material 2 2
Contamination /Decontamination Problem 2 2
Device Dislodged or Dislocated 2 2
Appropriate Term/Code Not Available 2 2
Sharp Edges 1 1
Device Contaminated During Manufacture or Shipping 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Deformation 1 1
Material Integrity Problem 1 1
Output Problem 1 1
Insufficient Information 1 1
Connection Problem 1 1
Detachment of Device or Device Component 1 1
Device Damaged by Another Device 1 1
Difficult to Open or Remove Packaging Material 1 1
Defective Component 1 1
Component Missing 1 1
Dent in Material 1 1
Retraction Problem 1 1
Material Separation 1 1
Contamination 1 1
Crack 1 1
Fire 1 1
Difficult to Insert 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 17 17
Foreign Body In Patient 6 6
No Known Impact Or Consequence To Patient 5 5
Insufficient Information 5 5
Needle Stick/Puncture 2 2
No Patient Involvement 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Cerebrospinal Fluid Leakage 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 Centurion Medical Products Corporation II Feb-05-2020
3 Centurion Medical Products Corporation II Oct-31-2019
4 Centurion Medical Products Corporation II Oct-09-2019
5 Centurion Medical Products Corporation II Aug-06-2019
6 MEDLINE INDUSTRIES, LP - Northfield II Mar-29-2024
7 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
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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