TPLC - Total Product Life Cycle

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Device	tubing, noninvasive
Regulation Description	Vacuum-powered body fluid suction apparatus.
Product Code	GAZ
Regulation Number	880.6740
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Defective Device	72	72
Detachment of Device or Device Component	33	34
Suction Failure	10	10
Defective Component	9	9
Fitting Problem	8	8
Suction Problem	6	6
Disconnection	3	3
Gas/Air Leak	3	3
Complete Blockage	3	3
Obstruction of Flow	3	3
Leak/Splash	3	3
Material Twisted/Bent	3	3
Failure to Cut	3	3
No Flow	3	3
Break	2	2
Product Quality Problem	2	2
Material Rupture	2	2
Key or Button Unresponsive/not Working	2	2
Decrease in Suction	2	2
Backflow	2	2
Material Separation	1	1
Difficult to Remove	1	1
Separation Problem	1	1
Appropriate Device Problem Term/Code Not Available	1	1
Pressure Problem	1	1
Failure to Advance	1	1
Loose or Intermittent Connection	1	1
Connection Problem	1	1
No Pressure	1	1
Radiofrequency Interference (RFI)	1	1
Ejection Problem	1	1
Component Missing	1	1
Positioning Problem	1	1
Failure to Prime	1	1
Filling Problem	1	1
Contamination /Decontamination Problem	1	1
Inability to Irrigate	1	1
Material Split, Cut or Torn	1	1
Mechanical Problem	1	1
Insufficient Flow or Under Infusion	1	1
Improper Flow or Infusion	1	1
Failure to Conduct	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	169	170
Insufficient Information	28	28
Bradycardia	1	1
Hypoxia	1	1
Retinal Tear	1	1
Endophthalmitis	1	1
Vitreous Hemorrhage	1	1
Intraocular Pressure Increased	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	DeRoyal Industries Inc	II	Mar-05-2025