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	227	227
Crack	37	37
Disconnection	15	15
Leak/Splash	10	10
Break	10	10
Obstruction of Flow	8	8
No Flow	8	8
Material Puncture/Hole	7	7
Defective Component	5	5
Backflow	5	5
Complete Blockage	4	4
Material Separation	3	3
Pressure Problem	2	2
Difficult to Flush	2	2
Material Discolored	2	2
Improper Flow or Infusion	2	2
Insufficient Flow or Under Infusion	2	2
Device Contamination with Chemical or Other Material	2	2
Fracture	2	2
Increase in Pressure	2	2
Protective Measures Problem	2	2
Restricted Flow rate	1	1
Filtration Problem	1	1
Defective Device	1	1
Therapeutic or Diagnostic Output Failure	1	1
Air/Gas in Device	1	1
Gas/Air Leak	1	1
Audible Prompt/Feedback Problem	1	1
Failure to Prime	1	1
Product Quality Problem	1	1
Tear, Rip or Hole in Device Packaging	1	1
Detachment of Device or Device Component	1	1
No Apparent Adverse Event	1	1
Connection Problem	1	1
Priming Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	238	238
No Consequences Or Impact To Patient	51	51
Insufficient Information	21	21
No Known Impact Or Consequence To Patient	5	5
Low Blood Pressure/ Hypotension	3	3
High Blood Pressure/ Hypertension	2	2
No Patient Involvement	2	2
Fever	1	1
Tachycardia	1	1

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