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	42	42
Detachment of Device or Device Component	39	40
Suction Failure	11	11
Fitting Problem	8	8
Suction Problem	8	8
Defective Component	7	7
Gas/Air Leak	5	5
Disconnection	4	4
Break	4	4
Material Twisted/Bent	4	4
Leak/Splash	3	3
No Flow	3	3
Device Contamination with Chemical or Other Material	3	3
Complete Blockage	3	3
Material Separation	3	3
Loose or Intermittent Connection	2	2
Product Quality Problem	2	2
Material Rupture	2	2
Failure to Cut	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
Obstruction of Flow	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	139	140
Insufficient Information	21	21
No Consequences Or Impact To Patient	12	12
No Known Impact Or Consequence To Patient	4	4
Vitreous Hemorrhage	2	2
Intraocular Pressure Increased	1	1
Endophthalmitis	1	1
Foreign Body In Patient	1	1
No Patient Involvement	1	1
Bradycardia	1	1
Retinal Tear	1	1

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