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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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
2018 30 30
2019 19 19
2020 31 31
2021 23 23
2022 21 21
2023 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Material Deformation 18 18
Break 17 17
Material Too Rigid or Stiff 16 16
Leak/Splash 9 9
Material Puncture/Hole 7 7
Fluid/Blood Leak 6 6
Disconnection 6 6
Material Integrity Problem 6 6
Material Twisted/Bent 6 6
Adverse Event Without Identified Device or Use Problem 6 6
Malposition of Device 5 5
Detachment of Device or Device Component 5 5
Device Markings/Labelling Problem 5 5
Material Separation 5 5
Difficult to Remove 3 3
Migration or Expulsion of Device 3 3
Crack 3 3
Hole In Material 3 3
Obstruction of Flow 3 3
Component Missing 3 3
Material Split, Cut or Torn 3 3
No Flow 3 3
Device Fell 2 2
Air/Gas in Device 2 2
Deformation Due to Compressive Stress 2 2
Appropriate Term/Code Not Available 2 2
Migration 2 2
Defective Device 2 2
Mechanical Problem 2 2
Material Rupture 2 2
Stretched 2 2
Use of Device Problem 2 2
Defective Component 1 1
Unraveled Material 1 1
Sticking 1 1
Unable to Obtain Readings 1 1
Misassembled 1 1
Delivered as Unsterile Product 1 1
Occlusion Within Device 1 1
Inadequate Instructions for Healthcare Professional 1 1
Kinked 1 1
Incorrect Measurement 1 1
Material Discolored 1 1
Fracture 1 1
Material Fragmentation 1 1
Entrapment of Device 1 1
Restricted Flow rate 1 1
Inaccurate Flow Rate 1 1
Complete Blockage 1 1
Device Alarm System 1 1
Partial Blockage 1 1
Device Displays Incorrect Message 1 1
Incomplete or Missing Packaging 1 1
Structural Problem 1 1
Failure to Advance 1 1
Failure to Disconnect 1 1
Device Dislodged or Dislocated 1 1
Device Contamination with Chemical or Other Material 1 1
Infusion or Flow Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Mechanical Jam 1 1
Material Too Soft/Flexible 1 1
Patient Device Interaction Problem 1 1
Connection Problem 1 1
Positioning Problem 1 1
Insufficient Information 1 1
Physical Resistance/Sticking 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 34 34
No Clinical Signs, Symptoms or Conditions 27 27
Insufficient Information 17 17
No Information 15 15
Foreign Body In Patient 11 11
No Consequences Or Impact To Patient 10 10
Vaso-Vagal Response 6 6
Bradycardia 6 6
Pneumothorax 5 5
Bowel Perforation 5 5
Vomiting 3 3
Perforation 3 3
Internal Organ Perforation 3 3
Nausea 2 2
Abdominal Distention 2 2
No Patient Involvement 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Stomach Ulceration 1 1
Device Embedded In Tissue or Plaque 1 1
Pressure Sores 1 1
Injury 1 1
Respiratory Failure 1 1
Pain 1 1
Chest Pain 1 1
Hypoglycemia 1 1

Recalls
Manufacturer Recall Class Date Posted
1 C.R. Bard, Inc. II Apr-11-2018
2 Canadian Hospital Specialties II Aug-15-2019
3 Canadian Hospital Specialties II Jan-11-2019
4 Canadian Hospital Specialties II Jul-13-2018
5 ConvaTec, Inc II Mar-21-2019
6 DeRoyal Industries Inc II Aug-20-2019
7 DeRoyal Industries Inc II Jan-16-2019
8 ICU Medical, Inc. II Sep-09-2022
9 Kentec Medical, Inc II Jul-08-2020
10 Neomed Inc II Oct-10-2018
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