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	342	342
Inflation Problem	186	186
Leak/Splash	179	179
Break	143	143
Detachment of Device or Device Component	116	116
Disconnection	89	89
Crack	83	83
Defective Component	58	58
Material Separation	50	50
Material Split, Cut or Torn	49	49
Material Puncture/Hole	48	48
Fluid/Blood Leak	46	46
Contamination /Decontamination Problem	45	45
Connection Problem	45	45
Component Missing	43	43
Unintended Deflation	40	40
Device Markings/Labelling Problem	37	37
Fracture	37	37
Separation Problem	31	31
Defective Device	28	28
Obstruction of Flow	25	25
Deflation Problem	24	24
Incomplete or Missing Packaging	22	22
Use of Device Problem	21	21
Decrease in Pressure	20	20
Material Deformation	20	20
Loose or Intermittent Connection	19	19
Fitting Problem	16	16
Suction Problem	16	16
Device Damaged Prior to Use	16	16
Insufficient Information	16	16
Mechanical Problem	15	15
Tear, Rip or Hole in Device Packaging	15	15
Inadequacy of Device Shape and/or Size	14	14
Pressure Problem	14	14
Material Rupture	13	13
Difficult to Insert	13	13
Moisture or Humidity Problem	11	11
Gel Leak	11	11
Material Discolored	11	11
Material Twisted/Bent	10	10
Patient Device Interaction Problem	10	10
Device Dislodged or Dislocated	9	9
Nonstandard Device	9	9
Material Fragmentation	9	9
Complete Blockage	8	8
Physical Resistance/Sticking	8	8
Material Too Soft/Flexible	8	8
Deformation Due to Compressive Stress	8	8
Misconnection	7	7

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1554	1554
Insufficient Information	224	224
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
Hypoxia	7	7
Hypoventilation	6	6
Bradycardia	6	6
Aspiration Pneumonitis	6	6
Hemorrhage/Bleeding	6	6
No Patient Involvement	5	5
Cardiac Arrest	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Aspiration/Inhalation	4	4
Fever	3	3
Abrasion	3	3
Fistula	3	3
Blister	2	2
Ventilator Dependent	2	2
Skin Inflammation/ Irritation	2	2
Brain Injury	2	2
Failure of Implant	2	2
Foreign Body In Patient	2	2
Chest Pain	2	2
Device Embedded In Tissue or Plaque	2	2
Swelling/ Edema	2	2
Pneumonia	2	2
Pneumothorax	2	2
Sore Throat	1	1
Infiltration into Tissue	1	1
Low Blood Pressure/ Hypotension	1	1
Respiratory Failure	1	1
Unspecified Respiratory Problem	1	1
Stomatitis	1	1
Salivary Hypersecretion	1	1
Bronchospasm	1	1
Forced Expiratory Volume Decreased	1	1
Chemosis	1	1
Bruise/Contusion	1	1
Hematemesis	1	1
Choking	1	1
Pain	1	1
Respiratory Tract Infection	1	1
Discomfort	1	1