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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device connector, catheter
Regulation Description Introduction/drainage catheter and accessories.
Product CodeGCD
Regulation Number 878.4200
Device Class 1

MDR Year MDR Reports MDR Events
2016 3 3
2017 4 4
2018 4 4
2019 6 6
2020 3 3
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 7 7
Fluid Leak 2 2
Delivered as Unsterile Product 2 2
Device Contaminated During Manufacture or Shipping 2 2
Detachment Of Device Component 2 2
Component Falling 1 1
Leak/Splash 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Unintended Movement 1 1
Physical Resistance/Sticking 1 1
Defective Component 1 1
Connection Problem 1 1
Device Contamination with Chemical or Other Material 1 1
No Device Output 1 1
Unsealed Device Packaging 1 1
Difficult to Remove 1 1
Material Separation 1 1
Failure to Deliver 1 1
Defective Device 1 1
Packaging Problem 1 1
Bent 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 5 5
No Patient Involvement 4 4
No Consequences Or Impact To Patient 3 3
Device Embedded In Tissue or Plaque 3 3
No Information 2 2
Foreign Body In Patient 2 2
No Code Available 1 1
No Clinical Signs, Symptoms or Conditions 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Teleflex Medical II May-22-2017
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