TPLC - Total Product Life Cycle

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Device	filter, infusion line
Regulation Description	Intravascular administration set.
Product Code	FPB
Regulation Number	880.5440
Device Class	2

Premarket Reviews
Manufacturer	Decision
HANGZHOU QIANTANG LONGYUE BIOTECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	244	245
Crack	38	38
Disconnection	13	13
Leak/Splash	11	11
Break	11	11
No Flow	8	8
Obstruction of Flow	7	7
Material Puncture/Hole	5	5
Backflow	5	5
Defective Component	4	4
Complete Blockage	3	3
Material Separation	3	3
Detachment of Device or Device Component	3	3
Increase in Pressure	3	3
Pressure Problem	2	2
Difficult to Flush	2	2
Air/Gas in Device	2	2
Material Discolored	2	2
Improper Flow or Infusion	2	2
Failure to Prime	2	2
Fracture	2	2
Protective Measures Problem	2	2
Connection Problem	2	2
Material Split, Cut or Torn	1	1
Filtration Problem	1	1
Defective Device	1	1
Contamination	1	1
Patient Device Interaction Problem	1	1
Use of Device Problem	1	1
Gas/Air Leak	1	1
Insufficient Flow or Under Infusion	1	1
Audible Prompt/Feedback Problem	1	1
Material Deformation	1	1
Product Quality Problem	1	1
Tear, Rip or Hole in Device Packaging	1	1
No Apparent Adverse Event	1	1
Priming Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	268	269
No Consequences Or Impact To Patient	42	42
Insufficient Information	21	21
Low Blood Pressure/ Hypotension	3	3
High Blood Pressure/ Hypertension	2	2
Fever	1	1
Tachycardia	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Smiths Medical ASD Inc.	II	Apr-21-2021