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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
2017 34 34
2018 30 30
2019 19 19
2020 31 31
2021 23 23
2022 19 19
2023 54 54
2024 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Break 29 29
Adverse Event Without Identified Device or Use Problem 24 24
Material Deformation 18 18
Malposition of Device 16 16
Material Too Rigid or Stiff 16 16
Leak/Splash 10 10
Fluid/Blood Leak 10 10
Material Integrity Problem 10 10
Material Puncture/Hole 9 9
Disconnection 8 8
Insufficient Information 8 8
Nonstandard Device 7 7
Material Twisted/Bent 6 6
Detachment of Device or Device Component 6 6
Obstruction of Flow 6 6
Device Markings/Labelling Problem 5 5
Difficult to Remove 5 5
Positioning Problem 5 5
Appropriate Term/Code Not Available 4 4
Hole In Material 4 4
Crack 4 4
Material Fragmentation 3 3
Mechanical Problem 3 3
Migration or Expulsion of Device 3 3
No Flow 3 3
Component Missing 3 3
Defective Device 3 3
Material Separation 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
Use of Device Problem 2 2
Volume Accuracy Problem 2 2
Device Contamination with Chemical or Other Material 2 2
Deformation Due to Compressive Stress 2 2
Kinked 2 2
Occlusion Within Device 2 2
Material Rupture 2 2
Fracture 2 2
Entrapment of Device 2 2
Restricted Flow rate 1 1
Inaccurate Flow Rate 1 1
Material Discolored 1 1
Burst Container or Vessel 1 1
Complete Blockage 1 1
Detachment Of Device Component 1 1
Air Leak 1 1
Device Alarm System 1 1
Bent 1 1
Partial Blockage 1 1
Product Quality Problem 1 1
Unable to Obtain Readings 1 1
Material Opacification 1 1
Delivered as Unsterile Product 1 1
Inadequate Instructions for Healthcare Professional 1 1
Misassembled 1 1
Loose or Intermittent Connection 1 1
Incorrect Measurement 1 1
Connection Problem 1 1
Patient-Device Incompatibility 1 1
Device Operates Differently Than Expected 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
Manufacturing, Packaging or Shipping Problem 1 1
Mechanical Jam 1 1
Mechanics Altered 1 1
Improper or Incorrect Procedure or Method 1 1
Defective Component 1 1
Device Slipped 1 1
Sticking 1 1
Unraveled Material 1 1
Device Displays Incorrect Message 1 1
Out-Of-Box Failure 1 1
Incomplete or Missing Packaging 1 1
Structural Problem 1 1
Failure to Advance 1 1
Failure to Disconnect 1 1
Physical Resistance 1 1
Material Too Soft/Flexible 1 1
Patient Device Interaction Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 49 49
No Clinical Signs, Symptoms or Conditions 33 33
Insufficient Information 23 23
No Information 22 22
Foreign Body In Patient 19 19
No Consequences Or Impact To Patient 13 13
Bowel Perforation 12 12
Unspecified Infection 10 10
Perforation 8 8
Pneumothorax 8 8
Bradycardia 8 8
Vomiting 6 6
Internal Organ Perforation 6 6
Vaso-Vagal Response 6 6
Abdominal Distention 5 5
Low Blood Pressure/ Hypotension 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
No Patient Involvement 4 4
Hematuria 3 3
Nausea 2 2
No Code Available 2 2
Device Embedded In Tissue or Plaque 2 2
Abscess 2 2
Apnea 1 1
Abnormal Blood Gases 1 1
Chest Pain 1 1
Pulmonary Emphysema 1 1
Hemorrhage/Bleeding 1 1
Hyperglycemia 1 1
Hypoglycemia 1 1
Pain 1 1
Laceration(s) 1 1
Electrolyte Imbalance 1 1
Skin Discoloration 1 1
Stomach Ulceration 1 1
Lethargy 1 1
Ascites 1 1
Rupture 1 1
Pressure Sores 1 1
Injury 1 1
Respiratory Failure 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-22-2017
10 Kentec Medical, Inc II Jul-08-2020
11 Neomed Inc II Oct-10-2018
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