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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
Regulation Description Gastrointestinal tube and accessories.
Definition To facilitate enteral specific connections.
Product CodePIF
Regulation Number 876.5980
Device Class 2


Premarket Reviews
ManufacturerDecision
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS 1
CARDINAL HEALTH
  SUBSTANTIALLY EQUIVALENT 1
CEDIC S.R.L.
  SUBSTANTIALLY EQUIVALENT 2
CONOD MEDICAL CO., LIMITED
  SUBSTANTIALLY EQUIVALENT 1
GBUK ENTERAL LIMITED
  SUBSTANTIALLY EQUIVALENT 1
GBUK GROUP LTD
  SUBSTANTIALLY EQUIVALENT 1
MAQUET CRITICAL CARE AB
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
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
XERIDIEM MEDICAL DEVICES
  SUBSTANTIALLY EQUIVALENT 1
XERIDIEM MEDICAL DEVICES, A SPECTRUM PLASTICS GROUP COMPANY
  SUBSTANTIALLY EQUIVALENT - KIT 1

MDR Year MDR Reports MDR Events
2016 44 44
2017 17 17
2018 17 17
2019 28 28
2020 70 70
2021 60 60

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid Leak 40 40
Detachment of Device or Device Component 23 23
Adverse Event Without Identified Device or Use Problem 18 18
Device Operates Differently Than Expected 15 15
Obstruction of Flow 14 14
Fracture 13 13
Complete Blockage 11 11
Crack 11 11
Break 10 10
Difficult to Advance 10 10
Physical Resistance/Sticking 8 8
Leak/Splash 8 8
Burst Container or Vessel 7 7
Occlusion Within Device 6 6
Decrease in Suction 6 6
Detachment Of Device Component 5 5
Suction Problem 5 5
Device Dislodged or Dislocated 4 4
Material Twisted/Bent 4 4
Migration or Expulsion of Device 4 4
Use of Device Problem 4 4
Entrapment of Device 4 4
Partial Blockage 3 3
Disconnection 3 3
Material Rupture 3 3
Suction Failure 3 3
Material Separation 3 3
Human-Device Interface Problem 3 3
Torn Material 3 3
No Flow 2 2
Protective Measures Problem 2 2
Material Puncture/Hole 2 2
Deflation Problem 2 2
Material Integrity Problem 2 2
Poor Quality Image 2 2
Failure to Analyze Signal 2 2
Malposition of Device 2 2
Connection Problem 1 1
Device Markings/Labelling Problem 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Device Contamination with Chemical or Other Material 1 1
Material Deformation 1 1
Migration 1 1
Improper or Incorrect Procedure or Method 1 1
Insufficient Flow or Under Infusion 1 1
Device Displays Incorrect Message 1 1
Product Quality Problem 1 1
Device Appears to Trigger Rejection 1 1
Loose or Intermittent Connection 1 1
Fail-Safe Design Failure 1 1
Contamination 1 1
Material Discolored 1 1
No Display/Image 1 1
Flushing Problem 1 1
Difficult to Remove 1 1
Material Too Rigid or Stiff 1 1
Nonstandard Device 1 1
Particulates 1 1
Material Fragmentation 1 1
Melted 1 1
Split 1 1
Separation Failure 1 1
Difficult to Open or Close 1 1
No Apparent Adverse Event 1 1
Device Handling Problem 1 1
Material Split, Cut or Torn 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 57 57
No Known Impact Or Consequence To Patient 49 49
No Consequences Or Impact To Patient 45 45
Unspecified Infection 21 21
Feeding Problem 19 19
Insufficient Information 10 10
Vomiting 6 6
No Code Available 5 5
No Patient Involvement 4 4
No Information 3 3
Aspiration/Inhalation 3 3
Perforation 3 3
Abdominal Distention 3 3
Fluid Discharge 2 2
Low Oxygen Saturation 2 2
Death 2 2
Edema 1 1
Hemorrhage/Bleeding 1 1
Abdominal Pain 1 1
Bacterial Infection 1 1
Discomfort 1 1
Pain 1 1
Pneumothorax 1 1
Foreign Body In Patient 1 1
Missed Dose 1 1
Peritonitis 1 1
Ulcer 1 1
Malaise 1 1
Skin Inflammation 1 1
Sepsis 1 1
Strangulation 1 1
Dyspnea 1 1
Flatus 1 1
Gastritis 1 1
Failure of Implant 1 1
Inflammation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 GETINGE US SALES LLC III Apr-25-2019
2 Xeridiem Mediem Medical Devices Inc II Feb-26-2016
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