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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter (gastric, colonic, etc.), irrigation and aspiration
Product CodeKDH
Regulation Number 876.5980
Device Class 2

MDR Year MDR Reports MDR Events
2019 3 3
2022 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Crack 2 2
Complete Blockage 2 2
Degraded 2 2
Decrease in Suction 2 2
Failure to Deliver 1 1
Difficult to Open or Close 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Abdominal Distention 2 2
No Known Impact Or Consequence To Patient 2 2
No Code Available 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 MEDLINE INDUSTRIES, LP - Northfield II Mar-29-2024
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