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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 27 27
2024 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 13 13
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
Decrease in Suction 4 4
Leak/Splash 4 4
Nonstandard Device 3 3
Break 3 3
Insufficient Information 3 3
Component Misassembled 3 3
Inaccurate Information 2 2
Unclear Information 2 2
Device Handling Problem 2 2
Device Contamination with Chemical or Other Material 2 2
Material Twisted/Bent 2 2
Component Missing 2 2
Crack 2 2
Incorrect Measurement 2 2
Fracture 2 2
Inability to Irrigate 1 1
Flushing Problem 1 1
Burst Container or Vessel 1 1
Complete Blockage 1 1
Degraded 1 1
Disconnection 1 1
Inaccurate Flow Rate 1 1
Tear, Rip or Hole in Device Packaging 1 1
Obstruction of Flow 1 1
Malposition of Device 1 1
Connection Problem 1 1
Activation, Positioning or Separation Problem 1 1
Suction Problem 1 1
Fitting Problem 1 1
Defective Component 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Positioning Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Gas/Air Leak 1 1
Wrong Label 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 49 49
No Consequences Or Impact To Patient 14 14
No Known Impact Or Consequence To Patient 14 14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Insufficient Information 3 3
Vomiting 2 2
Airway Obstruction 2 2
Bradycardia 2 2
Laceration(s) 2 2
Perforation 2 2
Skin Discoloration 1 1
Internal Organ Perforation 1 1
Hemorrhage/Bleeding 1 1
Hyperglycemia 1 1
Low Blood Pressure/ Hypotension 1 1
Hematemesis 1 1
Unspecified Kidney or Urinary Problem 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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