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
1. K192511 Venner PneuX™ TT (Tracheostomy Tube) Size 7.0 mm, ...
VITALTEC CORPORATION
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Gas/Air Leak	425	426
Leak/Splash	197	200
Inflation Problem	194	196
Break	153	155
Detachment of Device or Device Component	123	125
Crack	108	109
Disconnection	98	100
Defective Component	61	61
Material Split, Cut or Torn	60	60
Material Puncture/Hole	57	57
Fluid/Blood Leak	55	55
Material Separation	53	53
Connection Problem	46	46
Contamination /Decontamination Problem	45	45
Unintended Deflation	43	43
Component Missing	43	43
Fracture	38	38
Device Markings/Labelling Problem	37	37
Deflation Problem	31	31
Separation Problem	31	32
Defective Device	28	30
Obstruction of Flow	25	26
Incomplete or Missing Packaging	22	22
Use of Device Problem	21	21
Pressure Problem	21	21
Nonstandard Device	20	20
Decrease in Pressure	20	20
Material Deformation	20	20
Loose or Intermittent Connection	19	19
Fitting Problem	19	19
Device Damaged Prior to Use	18	18
Material Rupture	18	18
Suction Problem	16	16
Insufficient Device Problem Information	16	16
Mechanical Problem	16	16
Tear, Rip or Hole in Device Packaging	15	15
Inadequacy of Device Shape and/or Size	14	14
Device Dislodged or Dislocated	14	14
Moisture or Humidity Problem	13	13
Difficult to Insert	12	12
Material Discolored	11	11
Patient Device Interaction Problem	11	12
Gel Leak	11	11
Complete Blockage	11	11
Degraded	10	10
Material Fragmentation	9	9
Material Twisted/Bent	9	9
Deformation Due to Compressive Stress	9	9
Material Too Soft/Flexible	8	8
Misconnection	7	7

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1790	1806
Insufficient Information	229	230
No Consequences Or Impact To Patient	74	74
Low Oxygen Saturation	38	39
Decreased Respiratory Rate	29	29
Airway Obstruction	16	18
Dyspnea	14	14
Extubate	13	13
Hypoxia	11	11
No Information	11	11
Unintended Extubation	10	10
Hypoventilation	9	9
Respiratory Insufficiency	9	9
Aspiration/Inhalation	8	8
Aspiration Pneumonitis	7	7
Bradycardia	6	6
Hemorrhage/Blood Loss/Bleeding	6	6
Cardiac Arrest	6	8
No Patient Involvement	5	7
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	5	5
Pneumonia	4	4
Abrasion	3	3
Fever	3	3
Fistula	3	3
Failure of Implant	2	5
Swelling/ Edema	2	2
Foreign Body In Patient	2	2
Chest Pain	2	2
Ventilator Dependent	2	2
Respiratory Tract Infection	2	2
Brain Injury	2	2
Pain	2	2
Diminished Pulse Pressure	2	2
Skin Inflammation/ Irritation	2	2
Respiratory Arrest	2	2
Blister	2	2
Device Embedded In Tissue or Plaque	2	2
Pneumothorax	2	2
Stomatitis	1	1
Loss of consciousness	1	1
Inflammation	1	1
Hyporesponsive to stimuli	1	1
Respiratory Distress Syndrome of Newborns	1	1
Apnea	1	1
Death	1	1
Loss Of Pulse	1	1
No Known Impact Or Consequence To Patient	1	17
Myocardial Hypertrophy	1	2
Thrombosis	1	1
Wound Dehiscence	1	1