Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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
CMT HEALTH PTE. LTD.
  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
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 3 3
2021 5 15
2022 2 2
2023 11 13
2024 34 34
2025 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Compatibility Problem 14 14
Insufficient Information 13 13
Device Markings/Labelling Problem 5 6
Fluid/Blood Leak 4 6
Break 3 3
Product Quality Problem 3 3
Leak/Splash 2 2
Entrapment of Device 2 2
Defective Device 2 4
Manufacturing, Packaging or Shipping Problem 2 12
Connection Problem 2 2
Device Contaminated During Manufacture or Shipping 1 1
Mechanical Problem 1 1
Volume Accuracy Problem 1 3
Crack 1 1
Fail-Safe Did Not Operate 1 1
Measurement System Incompatibility 1 1
Patient Device Interaction Problem 1 1
Air/Gas in Device 1 3
Device Difficult to Setup or Prepare 1 1
Free or Unrestricted Flow 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 48 50
Insufficient Information 10 20
No Known Impact Or Consequence To Patient 3 3
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
-
-