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U.S. Department of Health and Human Services

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


Premarket Reviews
ManufacturerDecision
VR MEDICAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
VYGON USA
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 19 19
2020 31 31
2021 24 25
2022 19 20
2023 55 55
2024 41 41
2025 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 33 33
Malposition of Device 31 31
Break 28 28
Material Deformation 18 18
Material Too Rigid or Stiff 16 16
Leak/Splash 9 9
Insufficient Information 9 9
Material Puncture/Hole 8 8
Material Integrity Problem 7 7
Disconnection 6 6
Detachment of Device or Device Component 5 5
Fluid/Blood Leak 4 4
Material Split, Cut or Torn 4 4
Material Twisted/Bent 4 4
Crack 4 4
Obstruction of Flow 4 4
Difficult to Remove 4 4
Material Separation 3 3
Material Rupture 3 3
Component Missing 3 3
Device Markings/Labelling Problem 3 3
Device Fell 2 2
Patient Device Interaction Problem 2 3
Air/Gas in Device 2 2
Complete Blockage 2 2
Infusion or Flow Problem 2 2
Physical Resistance/Sticking 2 2
Migration or Expulsion of Device 2 2
Migration 2 2
Fracture 2 2
Connection Problem 2 3
Defective Component 1 1
Difficult to Advance 1 1
Positioning Problem 1 1
Inadequate Instructions for Healthcare Professional 1 1
Patient-Device Incompatibility 1 1
Material Fragmentation 1 1
Material Discolored 1 1
Restricted Flow rate 1 1
Gas/Air Leak 1 1
Device Alarm System 1 1
Inaccurate Flow Rate 1 1
Material Perforation 1 1
Structural Problem 1 1
Incomplete or Missing Packaging 1 1
Partial Blockage 1 1
Incorrect Measurement 1 1
Mechanical Problem 1 1
Entrapment of Device 1 1
Failure to Advance 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 44 44
Insufficient Information 23 23
Foreign Body In Patient 21 21
No Known Impact Or Consequence To Patient 19 19
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 13 14
No Information 13 13
Bowel Perforation 12 12
Perforation 12 12
Unspecified Infection 11 11
Low Blood Pressure/ Hypotension 10 10
Bradycardia 9 9
Perforation of Esophagus 7 7
Vomiting 7 7
Pneumothorax 6 6
Abdominal Distention 6 6
Vaso-Vagal Response 6 6
Hematuria 5 5
Abscess 4 4
Internal Organ Perforation 3 3
Skin Discoloration 3 3
Hyperglycemia 3 3
No Consequences Or Impact To Patient 3 3
Hypoxia 3 3
Apnea 2 2
Nausea 2 2
Abnormal Blood Gases 2 2
Lethargy 2 2
Electrolyte Imbalance 2 2
Hemorrhage/Bleeding 2 2
Device Embedded In Tissue or Plaque 1 1
Distress 1 1
Respiratory Failure 1 1
Low Oxygen Saturation 1 1
Ascites 1 1
Pressure Sores 1 1
Gastrointestinal Regurgitation 1 1
Hypoglycemia 1 1
Choking 1 1
Pain 1 1
Laceration(s) 1 1
No Patient Involvement 1 1
Chest Pain 1 1
Stomach Ulceration 1 2
Laceration(s) of Esophagus 1 1
Pulmonary Emphysema 1 1
Adhesion(s) 1 1
Increased Intra-Peritoneal Volume (IIPV) 1 1
Necrosis 1 1
Unspecified Gastrointestinal Problem 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Canadian Hospital Specialties II Aug-15-2019
2 Canadian Hospital Specialties II Jan-11-2019
3 ConvaTec, Inc II Mar-21-2019
4 DeRoyal Industries Inc II Aug-20-2019
5 DeRoyal Industries Inc II Jan-16-2019
6 ICU Medical, Inc. II Sep-09-2022
7 Kentec Medical, Inc II Jul-08-2020
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