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 Code	PNR
Regulation Number	876.5980
Device Class	2

Premarket Reviews
Manufacturer	Decision
ANHUI TIANKANG MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
CAIR LGL
	SUBSTANTIALLY EQUIVALENT	1
CARDINALHEALTH
	SUBSTANTIALLY EQUIVALENT	1
CMT HEALTH PTE., LTD.
	SUBSTANTIALLY EQUIVALENT	1
JIANGSU CAINA MEDICAL CO.,LTD
	SUBSTANTIALLY EQUIVALENT	2
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

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
Fitting Problem	4	4
Break	3	3
Detachment of Device or Device Component	3	3
Loose or Intermittent Connection	3	3
Leak/Splash	2	2
Entrapment of Device	2	2
Mechanical Problem	2	2
Defective Device	2	4
Manufacturing, Packaging or Shipping Problem	2	12
Product Quality Problem	2	2
Connection Problem	2	2
Fluid/Blood Leak	2	4
Device Contaminated During Manufacture or Shipping	1	1
Volume Accuracy Problem	1	3
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	53	55
Insufficient Information	12	22
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