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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device tube, nasogastric
Regulation Description Gastrointestinal tube and accessories.
Product CodeBSS
Regulation Number 876.5980
Device Class 2

MDR Year MDR Reports MDR Events
2021 8 8
2022 22 26
2023 27 28
2024 14 14
2025 10 10
2026 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 15 15
Material Split, Cut or Torn 10 10
Suction Failure 9 9
Partial Blockage 6 6
Material Puncture/Hole 4 4
Decrease in Suction 4 4
Component Misassembled 4 5
Disconnection 3 3
Insufficient Information 3 3
Incorrect Measurement 3 4
Leak/Splash 2 2
Break 2 2
Unclear Information 2 2
Component Missing 2 3
Device Handling Problem 2 2
Device Contamination with Chemical or Other Material 2 2
Nonstandard Device 2 2
Inaccurate Information 2 2
Fitting Problem 1 2
Burst Container or Vessel 1 1
Entrapment of Device 1 1
Malposition of Device 1 1
Complete Blockage 1 1
Separation Failure 1 1
Wrong Label 1 1
Defective Component 1 1
Positioning Problem 1 1
Therapeutic or Diagnostic Output Failure 1 4
Material Fragmentation 1 1
Material Twisted/Bent 1 1
Inaccurate Flow Rate 1 1
Tear, Rip or Hole in Device Packaging 1 1
Fracture 1 1
Suction Problem 1 1
Connection Problem 1 1
Material Too Soft/Flexible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 65 67
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Insufficient Information 3 3
Foreign Body In Patient 2 2
Vomiting 2 2
Airway Obstruction 2 2
Adult Respiratory Distress Syndrome 1 1
Perforation of Esophagus 1 1
Perforation 1 1
Skin Discoloration 1 1
Discomfort 1 1
Hematemesis 1 1
Laceration(s) 1 4
Hyperglycemia 1 1
Unspecified Kidney or Urinary Problem 1 1
Bradycardia 1 1
Hemorrhage/Bleeding 1 1
Low Oxygen Saturation 1 1
Low Blood Pressure/ Hypotension 1 1

Recalls
Manufacturer Recall Class Date Posted
1 C.R. Bard Inc II Jan-25-2024
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