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	240	241
Crack	39	39
Disconnection	15	15
Leak/Splash	12	12
Break	11	11
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
Connection Problem	2	2
Material Split, Cut or Torn	1	1
Restricted Flow rate	1	1
Filtration Problem	1	1
Defective Device	1	1
Therapeutic or Diagnostic Output Failure	1	1
Contamination	1	1
Patient Device Interaction Problem	1	1
Air/Gas in Device	1	1
Use of Device Problem	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
Priming Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	254	255
No Consequences Or Impact To Patient	51	51
Insufficient Information	23	23
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