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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device tray, surgical
Regulation Description Manual surgical instrument for general use.
Product CodeLRP
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2016 8 8
2017 20 20
2018 8 8
2019 6 6
2020 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Device Contamination with Chemical or Other Material 9 9
Component Missing 5 5
Device Packaging Compromised 5 5
Manufacturing, Packaging or Shipping Problem 4 4
Hole In Material 3 3
Break 2 2
Device Dislodged or Dislocated 2 2
Packaging Problem 2 2
Appropriate Term/Code Not Available 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Device Contaminated During Manufacture or Shipping 2 2
Contamination /Decontamination Problem 2 2
Device Contamination With Biological Material 1 1
Difficult to Advance 1 1
Material Frayed 1 1
Sticking 1 1
Device Damaged Prior to Use 1 1
Defective Component 1 1
Device Displays Incorrect Message 1 1
Material Integrity Problem 1 1
Noise, Audible 1 1
Misassembly by Users 1 1
Insufficient Information 1 1
Human Factors Issue 1 1
Material Protrusion/Extrusion 1 1
Difficult to Open or Remove Packaging Material 1 1
Burst Container or Vessel 1 1
Unintended Ejection 1 1
Fluid Leak 1 1
Material Puncture/Hole 1 1
Device Damaged by Another Device 1 1
Bent 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 24 24
No Information 8 8
No Patient Involvement 5 5
No Consequences Or Impact To Patient 4 4
No Clinical Signs, Symptoms or Conditions 3 3
Cerebrospinal Fluid Leakage 1 1
Skin Irritation 1 1
Unspecified Infection 1 1
No Code Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 B. Braun Medical, Inc. II Nov-01-2016
2 Cardinal Health 200, LLC II Sep-25-2020
3 Cardinal Health 200, LLC II Jul-18-2018
4 Centurion Medical Products Corporation II Feb-05-2020
5 Centurion Medical Products Corporation II Oct-31-2019
6 Centurion Medical Products Corporation II Oct-09-2019
7 Centurion Medical Products Corporation II Aug-06-2019
8 Centurion Medical Products Corporation II Mar-17-2018
9 Medline Industries Inc II Jan-25-2020
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