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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device enteral syringes with enteral specific connectors
Definition Delivers nutrition, medication, or hydration orally or to a gastrointestinal tube or extension set using AAMI/CN3(PS):2014 compliant connectors.
Product CodePNR
Regulation Number 876.5980
Device Class 2


Premarket Reviews
ManufacturerDecision
AMSINO INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ANHUI TIANKANG MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CAIR LGL
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 4
INTERNATIONAL MEDICAL INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
INTERVENE GROUP LIMITED
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU CAINA MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
JIANGSU KANGBAO MEDICAL EQUIPMENT CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU MICSAFE MEDICAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU SHENLI MEDICAL PRODUCTION CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
JIANGYIN CAINA TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDELA, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
NEOMED, INC.
  SUBSTANTIALLY EQUIVALENT 4
NINGBO TIANYI MEDICAL APPLIANCE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
PENTAFERTE ITALIA S.R.L.
  SUBSTANTIALLY EQUIVALENT 2
SHANGHAI KINDLY ENTERPRISE DEVELOPMENT GROUP CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHANTOU WEALY MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHINVA ANDE HEALTHCARE APPARATUS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
U&U MEDICAL TECHNOLOGY CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
VR MEDICAL TECHNOLOGY
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 1 1
2017 3 3
2018 2 2
2019 8 8
2020 2 2
2021 5 5
2022 2 2
2023 11 11
2024 30 30

Device Problems MDRs with this Device Problem Events in those MDRs
Compatibility Problem 14 14
Insufficient Information 9 9
Device Markings/Labelling Problem 5 5
Break 4 4
Fluid/Blood Leak 4 4
Product Quality Problem 3 3
Device Contamination with Chemical or Other Material 3 3
Entrapment of Device 2 2
Volume Accuracy Problem 2 2
Defective Device 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Excess Flow or Over-Infusion 2 2
Connection Problem 2 2
Mechanical Problem 1 1
Physical Resistance/Sticking 1 1
Crack 1 1
Patient-Device Incompatibility 1 1
Fail-Safe Did Not Operate 1 1
Measurement System Incompatibility 1 1
Difficult to Remove 1 1
Patient Device Interaction Problem 1 1
Air/Gas in Device 1 1
Fail-Safe Design Failure 1 1
Imprecision 1 1
Device Difficult to Setup or Prepare 1 1
Gas/Air Leak 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Incorrect Measurement 1 1
Inadequacy of Device Shape and/or Size 1 1
Mechanical Jam 1 1
No Flow 1 1
Detachment Of Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 37 37
No Known Impact Or Consequence To Patient 11 11
Insufficient Information 10 10
No Consequences Or Impact To Patient 2 2
Death 1 1
No Information 1 1
Increased Intra-Peritoneal Volume (IIPV) 1 1
Adhesion(s) 1 1
Aspiration/Inhalation 1 1
No Patient Involvement 1 1
Abscess 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cardinal Health 200, LLC I Feb-02-2024
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