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
VITALTEC CORPORATION
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Gas/Air Leak	396	398
Inflation Problem	197	201
Leak/Splash	196	199
Break	155	157
Detachment of Device or Device Component	122	124
Disconnection	98	100
Crack	95	96
Defective Component	60	60
Material Split, Cut or Torn	57	57
Material Puncture/Hole	56	57
Fluid/Blood Leak	55	55
Material Separation	53	53
Connection Problem	46	46
Contamination /Decontamination Problem	45	45
Component Missing	43	43
Unintended Deflation	43	43
Device Markings/Labelling Problem	38	54
Fracture	37	37
Deflation Problem	32	32
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
Decrease in Pressure	20	20
Material Deformation	20	20
Nonstandard Device	20	20
Loose or Intermittent Connection	19	19
Fitting Problem	18	18
Pressure Problem	18	18
Device Damaged Prior to Use	18	18
Material Rupture	17	17
Suction Problem	16	16
Insufficient Information	16	16
Mechanical Problem	16	17
Tear, Rip or Hole in Device Packaging	15	15
Inadequacy of Device Shape and/or Size	14	14
Moisture or Humidity Problem	13	13
Device Dislodged or Dislocated	13	13
Difficult to Insert	13	13
Material Discolored	11	11
Patient Device Interaction Problem	11	12
Gel Leak	11	11
Complete Blockage	11	11
Degraded	10	10
Material Twisted/Bent	10	10
Material Fragmentation	9	9
Deformation Due to Compressive Stress	9	9
Physical Resistance/Sticking	8	8
Material Too Soft/Flexible	8	8

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1711	1727
Insufficient Information	227	228
No Consequences Or Impact To Patient	74	74
Low Oxygen Saturation	35	36
Decreased Respiratory Rate	29	29
Airway Obstruction	16	18
Dyspnea	13	13
Extubate	13	13
No Information	11	11
Hypoxia	10	10
Unintended Extubation	10	10
Aspiration/Inhalation	8	8
Hypoventilation	8	8
Respiratory Insufficiency	8	8
Aspiration Pneumonitis	7	7
Bradycardia	6	6
Cardiac Arrest	6	8
Hemorrhage/Bleeding	6	6
No Patient Involvement	5	7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
Pneumonia	4	4
Fever	3	3
Fistula	3	3
Abrasion	3	3
Pneumothorax	2	2
Brain Injury	2	2
Chest Pain	2	2
Failure of Implant	2	5
Diminished Pulse Pressure	2	2
Foreign Body In Patient	2	2
Blister	2	2
Skin Inflammation/ Irritation	2	2
Ventilator Dependent	2	2
Swelling/ Edema	2	2
Device Embedded In Tissue or Plaque	2	2
Sore Throat	1	1
Laceration(s) of Esophagus	1	1
Respiratory Failure	1	1
Confusion/ Disorientation	1	1
Loss Of Pulse	1	1
Blood Loss	1	1
Bronchospasm	1	1
Loss of consciousness	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 Arrest	1	1