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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device tray, surgical, needle
Product CodeFSH
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2017 18 18
2018 9 9
2019 4 4
2020 2 2
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Unsealed Device Packaging 20 20
Component Misassembled 3 3
Break 3 3
Tear, Rip or Hole in Device Packaging 2 2
Bent 2 2
Use of Device Problem 1 1
Device Disinfection Or Sterilization Issue 1 1
Device Contamination with Chemical or Other Material 1 1
Material Integrity Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Packaging Problem 1 1
Appropriate Term/Code Not Available 1 1
Detachment Of Device Component 1 1
Component Falling 1 1
Entrapment of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Information 10 10
No Patient Involvement 9 9
No Known Impact Or Consequence To Patient 6 6
Not Applicable 4 4
Foreign Body In Patient 2 2
Needle Stick/Puncture 2 2
Unspecified Infection 1 1
Laceration(s) 1 1
No Consequences Or Impact To Patient 1 1
No Clinical Signs, Symptoms or Conditions 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Carefusion 2200 Inc II Apr-18-2018
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