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
Detachment of Device or Device Component	38	38
Defective Device	20	20
Suction Failure	12	12
Fitting Problem	8	8
Suction Problem	8	8
Defective Component	6	6
Gas/Air Leak	5	5
Disconnection	4	4
Material Twisted/Bent	4	4
Leak/Splash	3	3
No Flow	3	3
Break	3	3
Device Contamination with Chemical or Other Material	3	3
Complete Blockage	3	3
Material Separation	3	3
Failure to Cut	3	3
Loose or Intermittent Connection	2	2
Product Quality Problem	2	2
Material Rupture	2	2
Decrease in Suction	2	2
Backflow	2	2
Key or Button Unresponsive/not Working	2	2
Filling Problem	2	2
Pressure Problem	2	2
Unintended Ejection	1	1
Component Missing	1	1
Improper Flow or Infusion	1	1
No Pressure	1	1
Insufficient Flow or Under Infusion	1	1
Ejection Problem	1	1
Difficult to Remove	1	1
Failure to Prime	1	1
Positioning Problem	1	1
Inability to Irrigate	1	1
Mechanical Problem	1	1
Failure to Conduct	1	1
Failure to Advance	1	1
Device Dislodged or Dislocated	1	1
Appropriate Term/Code Not Available	1	1
Separation Problem	1	1
Connection Problem	1	1
Device Contaminated During Manufacture or Shipping	1	1
Fluid/Blood Leak	1	1
Radiofrequency Interference (RFI)	1	1
Noise, Audible	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	120	120
Insufficient Information	19	19
No Consequences Or Impact To Patient	12	12
No Known Impact Or Consequence To Patient	4	4
Foreign Body In Patient	1	1
No Patient Involvement	1	1
Vitreous Hemorrhage	1	1

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