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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device enteral specific transition connectors
Definition Facilitates enteral specific connections between AAMI/CN3(PS):2014 compliant connectors and non ISO 80369-1 compliant legacy enteral connectors.
Product CodePIO
Regulation Number 876.5980
Device Class 2


Premarket Reviews
ManufacturerDecision
GBUK GROUP LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 5 5
2019 7 7
2020 6 6
2021 9 9
2022 5 5
2023 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Deliver 19 19
Separation Failure 3 3
Material Integrity Problem 3 3
Use of Device Problem 3 3
Connection Problem 2 2
Break 2 2
Crack 2 2
Leak/Splash 2 2
Difficult to Remove 1 1
Free or Unrestricted Flow 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Output Problem 1 1
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 16 16
No Clinical Signs, Symptoms or Conditions 11 11
Foreign Body In Patient 5 5
Choking 2 2
Insufficient Information 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Device Embedded In Tissue or Plaque 1 1
Cellulitis 1 1
Feeding Problem 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Applied Medical Technology Inc III Dec-23-2020
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