TPLC - Total Product Life Cycle

• Device: filter, infusion line
• Product Code: FPB
• Regulation Number: 880.5440
• Device Class: 2

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

MDR Year	MDR Reports	MDR Events
2019	31	31
2020	18	18
2021	160	160
2022	36	36
2023	39	39
2024	27	27

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	232	232
Crack	38	38
Disconnection	19	19
Material Puncture/Hole	9	9
Obstruction of Flow	9	9
No Flow	8	8
Break	7	7
Leak/Splash	6	6
Defective Component	5	5
Backflow	4	4
Complete Blockage	4	4
Device Contamination with Chemical or Other Material	3	3
Gas/Air Leak	2	2
Improper Flow or Infusion	2	2
Pressure Problem	2	2
Protective Measures Problem	2	2
Defective Device	2	2
Material Discolored	2	2
Difficult to Flush	2	2
Fracture	2	2
Insufficient Flow or Under Infusion	2	2
Increase in Pressure	2	2
Failure to Prime	2	2
Product Quality Problem	1	1
Reflux within Device	1	1
Tear, Rip or Hole in Device Packaging	1	1
Restricted Flow rate	1	1
Connection Problem	1	1
Contamination of Device Ingredient or Reagent	1	1
Detachment of Device or Device Component	1	1
Therapeutic or Diagnostic Output Failure	1	1
Audible Prompt/Feedback Problem	1	1
Priming Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	203	203
No Consequences Or Impact To Patient	71	71
Insufficient Information	19	19
No Known Impact Or Consequence To Patient	10	10
No Information	4	4
No Patient Involvement	3	3
Low Blood Pressure/ Hypotension	3	3
High Blood Pressure/ Hypertension	2	2
Fever	1	1
Tachycardia	1	1
Thrombus	1	1

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