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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device tube, nasogastric
Product CodeBSS
Regulation Number 876.5980
Device Class 2

MDR Year MDR Reports MDR Events
2019 14 14
2020 6 6
2021 8 8
2022 22 22
2023 28 28
2024 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 14 14
Suction Failure 9 9
Material Puncture/Hole 8 8
Partial Blockage 7 7
Device Markings/Labelling Problem 6 6
Material Split, Cut or Torn 5 5
Leak/Splash 4 4
Component Misassembled 4 4
Decrease in Suction 4 4
Nonstandard Device 3 3
Device Contamination with Chemical or Other Material 3 3
Incorrect Measurement 3 3
Unclear Information 3 3
Insufficient Information 3 3
Break 3 3
Component Missing 2 2
Material Twisted/Bent 2 2
Crack 2 2
Device Handling Problem 2 2
Fracture 2 2
Fitting Problem 2 2
Inaccurate Information 2 2
Disconnection 2 2
Inability to Irrigate 1 1
Complete Blockage 1 1
Wrong Label 1 1
Defective Component 1 1
Positioning Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Degraded 1 1
Material Fragmentation 1 1
Obstruction of Flow 1 1
Gas/Air Leak 1 1
Inaccurate Flow Rate 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Malposition of Device 1 1
Burst Container or Vessel 1 1
Tear, Rip or Hole in Device Packaging 1 1
Activation, Positioning or Separation Problem 1 1
Flushing Problem 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 54 54
No Known Impact Or Consequence To Patient 14 14
No Consequences Or Impact To Patient 14 14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Insufficient Information 3 3
Perforation 2 2
Vomiting 2 2
Laceration(s) 2 2
Bradycardia 2 2
Airway Obstruction 2 2
Adult Respiratory Distress Syndrome 1 1
Skin Discoloration 1 1
Foreign Body In Patient 1 1
Hyperglycemia 1 1
Hematemesis 1 1
Unspecified Kidney or Urinary Problem 1 1
Hemorrhage/Bleeding 1 1
Low Blood Pressure/ Hypotension 1 1
Internal Organ Perforation 1 1
Low Oxygen Saturation 1 1

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