TPLC - Total Product Life Cycle

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Device	tube, tracheostomy (w/wo connector)
Regulation Description	Tracheostomy tube and tube cuff.
Product Code	BTO
Regulation Number	868.5800
Device Class	2

Premarket Reviews
Manufacturer	Decision
TELEFLEX MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
VENNER MEDICAL (SINGAPORE) PTE LTD
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Gas/Air Leak	316	316
Leak/Splash	179	179
Inflation Problem	179	179
Break	136	136
Detachment of Device or Device Component	114	114
Disconnection	81	81
Crack	77	77
Defective Component	58	58
Material Separation	50	50
Material Puncture/Hole	48	48
Material Split, Cut or Torn	47	47
Connection Problem	45	45
Contamination /Decontamination Problem	45	45
Component Missing	43	43
Fluid/Blood Leak	43	43
Unintended Deflation	39	39
Device Markings/Labelling Problem	37	37
Fracture	36	36
Separation Problem	31	31
Defective Device	28	28
Obstruction of Flow	24	24
Deflation Problem	23	23
Incomplete or Missing Packaging	22	22
Use of Device Problem	21	21
Material Deformation	19	19
Loose or Intermittent Connection	18	18
Decrease in Pressure	17	17
Insufficient Information	16	16
Fitting Problem	16	16
Device Damaged Prior to Use	16	16
Tear, Rip or Hole in Device Packaging	15	15
Mechanical Problem	15	15
Inadequacy of Device Shape and/or Size	14	14
Difficult to Insert	13	13
Suction Problem	13	13
Material Rupture	13	13
Pressure Problem	12	12
Gel Leak	11	11
Material Discolored	11	11
Moisture or Humidity Problem	10	10
Material Twisted/Bent	10	10
Patient Device Interaction Problem	10	10
Nonstandard Device	9	9
Material Fragmentation	9	9
Device Dislodged or Dislocated	9	9
Physical Resistance/Sticking	8	8
Material Too Soft/Flexible	8	8
Complete Blockage	7	7
Degraded	7	7
Misconnection	7	7

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1484	1484
Insufficient Information	223	223
No Consequences Or Impact To Patient	74	74
Low Oxygen Saturation	30	30
Decreased Respiratory Rate	29	29
Airway Obstruction	15	15
Extubate	13	13
No Information	11	11
Dyspnea	9	9
Unintended Extubation	8	8
Respiratory Insufficiency	8	8
Aspiration Pneumonitis	6	6
Bradycardia	6	6
No Patient Involvement	5	5
Cardiac Arrest	5	5
Hemorrhage/Bleeding	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Hypoxia	4	4
Hypoventilation	4	4
Aspiration/Inhalation	4	4
Abrasion	3	3
Fever	3	3
Fistula	3	3
Foreign Body In Patient	2	2
Device Embedded In Tissue or Plaque	2	2
Swelling/ Edema	2	2
Skin Inflammation/ Irritation	2	2
Blister	2	2
Failure of Implant	2	2
Ventilator Dependent	2	2
Brain Injury	2	2
Chest Pain	2	2
Pneumonia	2	2
Pneumothorax	2	2
Pain	1	1
Perforation	1	1
Respiratory Distress	1	1
Thrombosis	1	1
Discomfort	1	1
Sore Throat	1	1
Laceration(s) of Esophagus	1	1
Respiratory Tract Infection	1	1
Obstruction/Occlusion	1	1
Forced Expiratory Volume Decreased	1	1
Diaphoresis	1	1
Needle Stick/Puncture	1	1
Choking	1	1
Respiratory Failure	1	1
Confusion/ Disorientation	1	1
Infiltration into Tissue	1	1