TPLC - Total Product Life Cycle

show TPLC since

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
1. K242921 5300600-5301000 Rota-Trach Disposable Standard Tra ...

Device Problems	MDRs with this Device Problem	Events in those MDRs
Gas/Air Leak	418	420
Inflation Problem	198	202
Leak/Splash	197	200
Break	166	168
Detachment of Device or Device Component	124	126
Crack	104	105
Disconnection	101	103
Defective Component	61	61
Material Split, Cut or Torn	59	59
Material Puncture/Hole	59	60
Fluid/Blood Leak	57	57
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
Pressure Problem	21	21
Decrease in Pressure	20	20
Material Deformation	20	20
Nonstandard Device	20	20
Fitting Problem	19	19
Loose or Intermittent Connection	19	19
Device Damaged Prior to Use	18	18
Material Rupture	18	18
Mechanical Problem	17	18
Suction Problem	16	16
Insufficient Information	16	16
Tear, Rip or Hole in Device Packaging	15	15
Device Dislodged or Dislocated	14	14
Inadequacy of Device Shape and/or Size	14	14
Moisture or Humidity Problem	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	1770	1786
Insufficient Information	229	230
No Consequences Or Impact To Patient	74	74
Low Oxygen Saturation	36	37
Decreased Respiratory Rate	29	29
Airway Obstruction	16	18
Extubate	13	13
Dyspnea	13	13
No Information	11	11
Unintended Extubation	10	10
Hypoxia	10	10
Hypoventilation	9	9
Respiratory Insufficiency	9	9
Aspiration/Inhalation	8	8
Aspiration Pneumonitis	7	7
Hemorrhage/Bleeding	6	6
Bradycardia	6	6
Cardiac Arrest	6	8
No Patient Involvement	5	7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
Pneumonia	4	4
Fistula	3	3
Abrasion	3	3
Fever	3	3
Device Embedded In Tissue or Plaque	2	2
Pneumothorax	2	2
Ventilator Dependent	2	2
Failure of Implant	2	5
Brain Injury	2	2
Swelling/ Edema	2	2
Pain	2	2
Respiratory Arrest	2	2
Respiratory Tract Infection	2	2
Chest Pain	2	2
Foreign Body In Patient	2	2
Skin Inflammation/ Irritation	2	2
Diminished Pulse Pressure	2	2
Blister	2	2
Distress	1	1
Bruise/Contusion	1	1
Hemoptysis	1	1
Stomatitis	1	1
Respiratory Failure	1	1
Low Blood Pressure/ Hypotension	1	1
Inflammation	1	1
Wound Dehiscence	1	1
Stacking Breaths	1	1
Perforation	1	1
Apnea	1	1
Loss of consciousness	1	1