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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
CAIR LGL
  SUBSTANTIALLY EQUIVALENT 2
CARDINAL HEALTH
  SUBSTANTIALLY EQUIVALENT 2
CEDIC S.R.L.
  SUBSTANTIALLY EQUIVALENT 2
CONOD MEDICAL CO., 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 1
MOSS TUBES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MPS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
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 LLC
  SUBSTANTIALLY EQUIVALENT 1
VESCO MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
VONCO PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
WILSON-COOK MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT - WITH DRUG 1
XERIDIEM MEDICAL DEVICES
  SUBSTANTIALLY EQUIVALENT 1
XERIDIEM MEDICAL DEVICES, A SPECTRUM PLASTICS GROUP COMPANY
  SUBSTANTIALLY EQUIVALENT - KIT 1

MDR Year MDR Reports MDR Events
2017 17 17
2018 17 17
2019 28 28
2020 70 70
2021 89 89
2022 56 56

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid Leak 58 58
Detachment of Device or Device Component 37 37
Adverse Event Without Identified Device or Use Problem 17 17
Obstruction of Flow 16 16
Device Dislodged or Dislocated 14 14
Fracture 14 14
Complete Blockage 12 12
Crack 12 12
Break 11 11
Unintended Deflation 8 8
Physical Resistance/Sticking 8 8
Burst Container or Vessel 7 7
Material Twisted/Bent 7 7
Use of Device Problem 7 7
Suction Problem 7 7
Decrease in Suction 6 6
Material Rupture 6 6
Leak/Splash 6 6
Occlusion Within Device 5 5
Entrapment of Device 4 4
Difficult to Advance 4 4
Migration or Expulsion of Device 4 4
Difficult to Remove 4 4
Material Separation 4 4
Human-Device Interface Problem 3 3
Suction Failure 3 3
Migration 3 3
Material Puncture/Hole 3 3
Torn Material 3 3
Material Split, Cut or Torn 3 3
No Apparent Adverse Event 2 2
Deflation Problem 2 2
Failure to Analyze Signal 2 2
Contamination /Decontamination Problem 2 2
Material Discolored 2 2
Material Integrity Problem 2 2
Detachment Of Device Component 2 2
Product Quality Problem 2 2
Improper or Incorrect Procedure or Method 2 2
Protective Measures Problem 2 2
Device Handling Problem 1 1
Patient Device Interaction Problem 1 1
Separation Failure 1 1
Fitting Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Device Appears to Trigger Rejection 1 1
Contamination 1 1
Poor Quality Image 1 1
Connection Problem 1 1
Device Markings/Labelling Problem 1 1
Device Displays Incorrect Message 1 1
Malposition of Device 1 1
Loose or Intermittent Connection 1 1
Manufacturing, Packaging or Shipping Problem 1 1
No Display/Image 1 1
Inadequate Instructions for Healthcare Professional 1 1
Nonstandard Device 1 1
Noise, Audible 1 1
No Flow 1 1
Split 1 1
Difficult to Open or Close 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 124 124
No Consequences Or Impact To Patient 44 44
No Known Impact Or Consequence To Patient 26 26
Insufficient Information 17 17
Unspecified Infection 16 16
Feeding Problem 7 7
Vomiting 6 6
Aspiration/Inhalation 5 5
Low Oxygen Saturation 4 4
No Code Available 4 4
No Patient Involvement 4 4
Perforation 3 3
Sepsis 3 3
Foreign Body In Patient 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Fluid Discharge 2 2
Peritonitis 2 2
No Information 2 2
Death 2 2
Abdominal Distention 2 2
Discomfort 2 2
Pain 2 2
Adult Respiratory Distress Syndrome 2 2
Cardiac Arrest 1 1
Purulent Discharge 1 1
Pneumothorax 1 1
Choking 1 1
Gastritis 1 1
Failure of Implant 1 1
Ulcer 1 1
Edema 1 1
Hemorrhage/Bleeding 1 1
Liver Damage/Dysfunction 1 1
Respiratory Arrest 1 1
Skin Inflammation/ Irritation 1 1
Abdominal Pain 1 1
Skin Inflammation 1 1
Respiratory Failure 1 1
Missed Dose 1 1
Renal Impairment 1 1
Erosion 1 1
Dehydration 1 1
Dyspnea 1 1
Low Blood Pressure/ Hypotension 1 1
Inflammation 1 1
Septic Shock 1 1
Strangulation 1 1
Viral Infection 1 1

Recalls
Manufacturer Recall Class Date Posted
1 GETINGE US SALES LLC III Apr-25-2019
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