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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
CARDINALHEALTH
  SUBSTANTIALLY EQUIVALENT 1
CHIRANA T.INJECTA,A.S.
  SUBSTANTIALLY EQUIVALENT 1
CMT HEALTH PTE., LTD.
  SUBSTANTIALLY EQUIVALENT 2
JIANGSU CAINA MEDICAL CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
NINGBO TIANYI MEDICAL APPLIANCE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
PENTAFERTE ITALIA S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
SHANTOU WEALY MEDICAL INSTRUMENT CO.,LTD
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2021 5 15
2022 2 2
2023 11 13
2024 34 34
2025 7 7
2026 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Compatibility Problem 14 14
Insufficient Device Problem Information 13 13
Fitting Problem 4 4
Loose or Intermittent Connection 2 2
Detachment of Device or Device Component 2 2
Mechanical Problem 2 2
Leak/Splash 1 1
Free or Unrestricted Flow 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 58 60
Insufficient Information 12 22
Adhesion(s) 1 1
Increased Intra-Peritoneal Volume (IIPV) 1 1
Abscess 1 1

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