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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device clamp, umbilical
Product CodeHFW
Regulation Number 884.4530
Device Class 2

MDR Year MDR Reports MDR Events
2014 1 1
2015 1 1
2016 1 1
2017 2 2
2018 7 7
2020 1 1
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Defective Device 3 3
Break 2 2
Appropriate Term/Code Not Available 2 2
Fail-Safe Did Not Operate 2 2
Patient Data Problem 1 1
Detachment Of Device Component 1 1
Device Slipped 1 1
Detachment of Device or Device Component 1 1
Device Operates Differently Than Expected 1 1
Device Damaged by Another Device 1 1
Device-Device Incompatibility 1 1
Difficult to Open or Close 1 1
Free or Unrestricted Flow 1 1
Therapeutic or Diagnostic Output Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Information 6 6
Hemorrhage/Bleeding 3 3
No Known Impact Or Consequence To Patient 2 2
Respiratory Distress Syndrome of Newborns 1 1
Injury 1 1
Blood Loss 1 1
Muscle Hypotonia 1 1
Abrasion 1 1
Cyanosis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cypress Medical Products LLC II May-08-2013
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