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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
BEIJING L&Z MEDICAL TECHNOLOGY DEVELOPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CAIR LGL
  SUBSTANTIALLY EQUIVALENT 2
CARDINAL HEALTH
  SUBSTANTIALLY EQUIVALENT 2
CEDIC S.R.L.
  SUBSTANTIALLY EQUIVALENT 2
GBUK GROUP LTD
  SUBSTANTIALLY EQUIVALENT 1
KB MEDICAL (GROUP) INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MOSS TUBES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MPS MEDICAL, 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
U DELIVER MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
VESCO MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
VESCO MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
VONCO PRODUCTS
  SUBSTANTIALLY EQUIVALENT 2
WILSON-COOK MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT - WITH DRUG 1
XERIDIEM MEDICAL DEVICES, A SPECTRUM PLASTICS GROUP COMPANY
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 28 28
2020 70 70
2021 89 89
2022 77 77
2023 96 96
2024 42 42

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 66 66
Detachment of Device or Device Component 64 64
Obstruction of Flow 32 32
Adverse Event Without Identified Device or Use Problem 29 29
Break 23 23
Device Dislodged or Dislocated 22 22
Unintended Deflation 19 19
Complete Blockage 13 13
Crack 13 13
Fracture 10 10
Material Rupture 10 10
Material Twisted/Bent 10 10
Suction Problem 9 9
Leak/Splash 9 9
Use of Device Problem 8 8
Physical Resistance/Sticking 8 8
Unintended Movement 7 7
Burst Container or Vessel 7 7
Decrease in Suction 6 6
Material Puncture/Hole 6 6
Difficult to Remove 6 6
Material Separation 6 6
Material Integrity Problem 6 6
Migration 4 4
Material Split, Cut or Torn 4 4
Difficult to Advance 4 4
No Apparent Adverse Event 3 3
Suction Failure 3 3
Malposition of Device 3 3
Deflation Problem 3 3
Material Discolored 2 2
Disconnection 2 2
Product Quality Problem 2 2
Contamination /Decontamination Problem 2 2
Defective Device 2 2
Failure to Analyze Signal 2 2
Improper or Incorrect Procedure or Method 2 2
Insufficient Information 2 2
Protective Measures Problem 2 2
Device Markings/Labelling Problem 2 2
Difficult to Open or Close 1 1
Device Contamination with Chemical or Other Material 1 1
Device Contaminated During Manufacture or Shipping 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Deformation 1 1
Therapeutic or Diagnostic Output Failure 1 1
No Flow 1 1
Noise, Audible 1 1
Patient Device Interaction Problem 1 1
Device Slipped 1 1
Stretched 1 1
Device Displays Incorrect Message 1 1
Connection Problem 1 1
Fitting Problem 1 1
Component Missing 1 1
Structural Problem 1 1
Separation Failure 1 1
Device Appears to Trigger Rejection 1 1
Inadequate Instructions for Healthcare Professional 1 1
Loose or Intermittent Connection 1 1
Nonstandard Device 1 1
Unsealed Device Packaging 1 1
No Display/Image 1 1
Entrapment of Device 1 1
Contamination 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 232 232
No Consequences Or Impact To Patient 37 37
Insufficient Information 24 24
No Known Impact Or Consequence To Patient 20 20
Unspecified Infection 14 14
Vomiting 10 10
Low Oxygen Saturation 8 8
Aspiration/Inhalation 8 8
Foreign Body In Patient 8 8
Bradycardia 6 6
Pneumothorax 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Bowel Perforation 4 4
Perforation 4 4
Feeding Problem 3 3
Hemorrhage/Bleeding 3 3
No Patient Involvement 3 3
No Code Available 3 3
Skin Inflammation/ Irritation 2 2
No Information 2 2
Fluid Discharge 2 2
Choking 2 2
Abdominal Distention 2 2
Abdominal Pain 2 2
Adult Respiratory Distress Syndrome 2 2
Death 2 2
Sepsis 2 2
Septic Shock 2 2
Internal Organ Perforation 2 2
Pain 2 2
Cardiac Arrest 1 1
Strangulation 1 1
Respiratory Failure 1 1
Missed Dose 1 1
Viral Infection 1 1
Peritonitis 1 1
Discomfort 1 1
Skin Inflammation 1 1
Dehydration 1 1
Purulent Discharge 1 1
Dyspnea 1 1
Edema 1 1
Erosion 1 1
Hypersensitivity/Allergic reaction 1 1
Low Blood Pressure/ Hypotension 1 1
Failure of Implant 1 1
Inflammation 1 1
Liver Damage/Dysfunction 1 1
Necrosis 1 1
Unintended Extubation 1 1
Multiple Organ Failure 1 1
Respiratory Arrest 1 1
Renal Impairment 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
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