Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device tube, feeding
Product CodeFPD
Regulation Number 876.5980
Device Class 2


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

MDR Year MDR Reports MDR Events
2019 19 19
2020 31 31
2021 23 23
2022 19 19
2023 55 55
2024 29 29

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 33 33
Break 26 26
Malposition of Device 25 25
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
Material Twisted/Bent 4 4
Fluid/Blood Leak 4 4
Difficult to Remove 4 4
Crack 3 3
Material Separation 3 3
Component Missing 3 3
Device Markings/Labelling Problem 3 3
Material Split, Cut or Torn 3 3
Physical Resistance/Sticking 2 2
Device Fell 2 2
Air/Gas in Device 2 2
Migration 2 2
Migration or Expulsion of Device 2 2
Obstruction of Flow 2 2
Material Rupture 2 2
Fracture 2 2
Complete Blockage 2 2
Device Alarm System 1 1
Partial Blockage 1 1
Entrapment of Device 1 1
Restricted Flow rate 1 1
Inaccurate Flow Rate 1 1
Material Fragmentation 1 1
Inadequate Instructions for Healthcare Professional 1 1
Loose or Intermittent Connection 1 1
Incorrect Measurement 1 1
Mechanical Problem 1 1
Device Slipped 1 1
Defective Component 1 1
Material Discolored 1 1
Structural Problem 1 1
Failure to Advance 1 1
Incomplete or Missing Packaging 1 1
Patient-Device Incompatibility 1 1
Deformation Due to Compressive Stress 1 1
Connection Problem 1 1
Material Too Soft/Flexible 1 1
Appropriate Term/Code Not Available 1 1
Patient Device Interaction Problem 1 1
Positioning Problem 1 1
Difficult to Advance 1 1
Difficult to Open or Close 1 1
Device Dislodged or Dislocated 1 1
Infusion or Flow Problem 1 1
Mechanical Jam 1 1
No Flow 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 35 35
Insufficient Information 23 23
Foreign Body In Patient 20 20
No Known Impact Or Consequence To Patient 19 19
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 13 13
No Information 13 13
Bowel Perforation 12 12
Low Blood Pressure/ Hypotension 10 10
Unspecified Infection 10 10
Perforation 10 10
Bradycardia 9 9
Vomiting 7 7
Vaso-Vagal Response 6 6
Abdominal Distention 6 6
Pneumothorax 6 6
Hematuria 5 5
Perforation of Esophagus 4 4
No Consequences Or Impact To Patient 3 3
Skin Discoloration 3 3
Internal Organ Perforation 3 3
Abscess 3 3
Hyperglycemia 3 3
Abnormal Blood Gases 2 2
Hemorrhage/Bleeding 2 2
Apnea 2 2
Nausea 2 2
Electrolyte Imbalance 2 2
Lethargy 2 2
Ascites 1 1
No Patient Involvement 1 1
Device Embedded In Tissue or Plaque 1 1
Low Oxygen Saturation 1 1
Respiratory Failure 1 1
Pressure Sores 1 1
Distress 1 1
Laceration(s) of Esophagus 1 1
Necrosis 1 1
Laceration(s) 1 1
Pain 1 1
Chest Pain 1 1
Pulmonary Emphysema 1 1
Hypoglycemia 1 1
Gastrointestinal Regurgitation 1 1
Stomach Ulceration 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
-
-