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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device gastrointestinal tubes with enteral specific connectors
Definition To facilitate enteral specific connections.
Product CodePIF
Regulation Number 876.5980
Device Class 2


Premarket Reviews
ManufacturerDecision
ANHUI TIANKANG MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
APPLIED MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS 1
CAIR LGL
  SUBSTANTIALLY EQUIVALENT 2
CARDINAL HEALTH
  SUBSTANTIALLY EQUIVALENT 2
CEDIC S.R.L.
  SUBSTANTIALLY EQUIVALENT 2
CONOD MEDICAL CO., LIMITED
  SUBSTANTIALLY EQUIVALENT 1
CORPAK MEDSYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 3
DEGANIA SILICONE, LTD.
  SUBSTANTIALLY EQUIVALENT 1
GBUK ENTERAL LIMITED
  SUBSTANTIALLY EQUIVALENT 1
GBUK GROUP LTD
  SUBSTANTIALLY EQUIVALENT 1
KB MEDICAL (GROUP) INC.
  SUBSTANTIALLY EQUIVALENT 1
MAQUET CRITICAL CARE AB
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 3
MOSS TUBES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MPS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
NESTLE HEALTHCARE NUTRITION, INC.
  SUBSTANTIALLY EQUIVALENT 1
ROCKFIELD MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
SYNCRO MEDICAL INNOVATIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS 1
THREE CIRCLES CONSULTING LIMITED
  SUBSTANTIALLY EQUIVALENT 1
TROVRX, INC. DBA TROVITA HEALTH SCIENCE
  SUBSTANTIALLY EQUIVALENT 1
U DELIVER MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 2
VESCO MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
VESCO MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
VESCO MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
VONCO PRODUCTS
  SUBSTANTIALLY EQUIVALENT 2
WILSON-COOK MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT - WITH DRUG 1
XERIDIEM (FORMERLY MRI)
  SUBSTANTIALLY EQUIVALENT 2
XERIDIEM MEDICAL DEVICES
  SUBSTANTIALLY EQUIVALENT 1
XERIDIEM MEDICAL DEVICES, A SPECTRUM PLASTICS GROUP COMPANY
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - KIT 1
ZEVEX, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 12 12
2016 44 44
2017 17 17
2018 17 17
2019 28 28
2020 70 70
2021 89 89
2022 77 77
2023 96 96
2024 23 23

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 71 71
Detachment of Device or Device Component 60 60
Adverse Event Without Identified Device or Use Problem 38 38
Obstruction of Flow 29 29
Break 25 25
Device Operates Differently Than Expected 19 19
Device Dislodged or Dislocated 19 19
Fracture 18 18
Unintended Deflation 18 18
Crack 16 16
Complete Blockage 14 14
Leak/Splash 12 12
Material Rupture 10 10
Difficult to Advance 10 10
Material Twisted/Bent 10 10
Suction Problem 9 9
Physical Resistance/Sticking 8 8
Use of Device Problem 7 7
Unintended Movement 7 7
Burst Container or Vessel 7 7
Decrease in Suction 6 6
Material Separation 6 6
Material Puncture/Hole 6 6
Difficult to Remove 6 6
Occlusion Within Device 6 6
Migration or Expulsion of Device 5 5
Detachment Of Device Component 5 5
Disconnection 5 5
Connection Problem 5 5
Material Split, Cut or Torn 5 5
Migration 4 4
Material Integrity Problem 4 4
Malposition of Device 4 4
Entrapment of Device 4 4
Deflation Problem 4 4
Partial Blockage 3 3
No Apparent Adverse Event 3 3
Human-Device Interface Problem 3 3
Torn Material 3 3
Protective Measures Problem 3 3
Suction Failure 3 3
Insufficient Information 2 2
No Flow 2 2
Contamination /Decontamination Problem 2 2
Device Markings/Labelling Problem 2 2
Split 2 2
Defective Device 2 2
Improper or Incorrect Procedure or Method 2 2
Fitting Problem 2 2
Material Discolored 2 2
Poor Quality Image 2 2
Nonstandard Device 2 2
Failure to Analyze Signal 2 2
Product Quality Problem 2 2
Device Appears to Trigger Rejection 1 1
Material Too Rigid or Stiff 1 1
Inadequacy of Device Shape and/or Size 1 1
Stretched 1 1
Unsealed Device Packaging 1 1
Particulates 1 1
Loose or Intermittent Connection 1 1
Melted 1 1
Material Fragmentation 1 1
Inadequate Instructions for Healthcare Professional 1 1
Device Alarm System 1 1
Fail-Safe Design Failure 1 1
Flushing Problem 1 1
No Display/Image 1 1
Application Program Problem: Dose Calculation Error 1 1
Contamination 1 1
Component Missing 1 1
Inaccurate Delivery 1 1
Structural Problem 1 1
Insufficient Flow or Under Infusion 1 1
Device Displays Incorrect Message 1 1
Separation Failure 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Application Program Problem: Medication Error 1 1
Device Handling Problem 1 1
Noise, Audible 1 1
Patient Device Interaction Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Deformation 1 1
Difficult to Open or Close 1 1
Device Contamination with Chemical or Other Material 1 1
Therapeutic or Diagnostic Output Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 219 219
No Known Impact Or Consequence To Patient 50 50
No Consequences Or Impact To Patient 47 47
Unspecified Infection 28 28
Feeding Problem 25 25
Insufficient Information 22 22
Vomiting 11 11
Aspiration/Inhalation 8 8
Foreign Body In Patient 8 8
Low Oxygen Saturation 8 8
Bradycardia 6 6
Pneumothorax 5 5
No Code Available 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
No Information 4 4
No Patient Involvement 4 4
Bowel Perforation 4 4
Perforation 4 4
Sepsis 3 3
Abdominal Distention 3 3
Choking 2 2
Underdose 2 2
Fluid Discharge 2 2
Peritonitis 2 2
Discomfort 2 2
Skin Inflammation/ Irritation 2 2
Septic Shock 2 2
Internal Organ Perforation 2 2
Failure of Implant 2 2
Pain 2 2
Hemorrhage/Bleeding 2 2
Hypoglycemia 2 2
Adult Respiratory Distress Syndrome 2 2
Death 2 2
Dehydration 2 2
Purulent Discharge 1 1
Dyspnea 1 1
Edema 1 1
Abdominal Pain 1 1
Bacterial Infection 1 1
Erosion 1 1
Low Blood Pressure/ Hypotension 1 1
Hypersensitivity/Allergic reaction 1 1
Cardiac Arrest 1 1
Flatus 1 1
Gastritis 1 1
Overdose 1 1
Inflammation 1 1
Liver Damage/Dysfunction 1 1
Necrosis 1 1
Strangulation 1 1
Viral Infection 1 1
Unintended Extubation 1 1
Multiple Organ Failure 1 1
Respiratory Arrest 1 1
Renal Impairment 1 1
Malaise 1 1
Loss of consciousness 1 1
Skin Inflammation 1 1
Ulcer 1 1
Respiratory Failure 1 1
Lethargy 1 1
Missed Dose 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation II Apr-11-2024
2 Boston Scientific Corporation II Feb-16-2024
3 GETINGE US SALES LLC III Apr-25-2019
4 MOOG Medical Devices Group II Dec-14-2015
5 Xeridiem Mediem Medical Devices Inc II Feb-26-2016
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