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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
Regulation Description Gastrointestinal tube and accessories.
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
ANHUI TIANKANG MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CAIR LGL
  SUBSTANTIALLY EQUIVALENT 1
CARDINAL HEALTH
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU CAINA MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
JIANGSU SHENLI MEDICAL PRODUCTION CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
NINGBO TIANYI MEDICAL APPLIANCE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
PENTAFERTE ITALIA S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
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

MDR Year MDR Reports MDR Events
2020 2 2
2021 5 5
2022 2 2
2023 11 11
2024 34 34
2025 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Compatibility Problem 14 14
Insufficient Information 12 12
Device Markings/Labelling Problem 5 5
Fluid/Blood Leak 4 4
Break 3 3
Entrapment of Device 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Product Quality Problem 2 2
Connection Problem 2 2
Mechanical Problem 1 1
Volume Accuracy Problem 1 1
Crack 1 1
Fail-Safe Did Not Operate 1 1
Defective Device 1 1
Measurement System Incompatibility 1 1
Patient Device Interaction Problem 1 1
Air/Gas in Device 1 1
Device Difficult to Setup or Prepare 1 1
Mechanical Jam 1 1
No Flow 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 43 43
Insufficient Information 10 10
No Known Impact Or Consequence To Patient 2 2
Increased Intra-Peritoneal Volume (IIPV) 1 1
Adhesion(s) 1 1
Abscess 1 1

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