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	350	350
Inflation Problem	188	188
Leak/Splash	181	181
Break	144	144
Detachment of Device or Device Component	116	116
Disconnection	91	91
Crack	87	87
Defective Component	58	58
Material Puncture/Hole	51	51
Material Separation	50	50
Material Split, Cut or Torn	50	50
Fluid/Blood Leak	48	48
Contamination /Decontamination Problem	45	45
Connection Problem	45	45
Component Missing	43	43
Unintended Deflation	40	40
Fracture	37	37
Device Markings/Labelling Problem	37	37
Separation Problem	31	31
Defective Device	28	28
Deflation Problem	27	27
Obstruction of Flow	25	25
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
Suction Problem	16	16
Insufficient Information	16	16
Device Damaged Prior to Use	16	16
Fitting Problem	16	16
Mechanical Problem	15	15
Tear, Rip or Hole in Device Packaging	15	15
Pressure Problem	14	14
Inadequacy of Device Shape and/or Size	14	14
Material Rupture	13	13
Difficult to Insert	13	13
Gel Leak	11	11
Moisture or Humidity Problem	11	11
Material Discolored	11	11
Patient Device Interaction Problem	10	10
Material Twisted/Bent	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
Difficult to Remove	7	7

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1577	1577
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
Aspiration Pneumonitis	6	6
Hypoventilation	6	6
Hemorrhage/Bleeding	6	6
Bradycardia	6	6
No Patient Involvement	5	5
Cardiac Arrest	5	5
Aspiration/Inhalation	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Abrasion	3	3
Fistula	3	3
Fever	3	3
Device Embedded In Tissue or Plaque	2	2
Pneumothorax	2	2
Blister	2	2
Ventilator Dependent	2	2
Skin Inflammation/ Irritation	2	2
Foreign Body In Patient	2	2
Chest Pain	2	2
Failure of Implant	2	2
Brain Injury	2	2
Pneumonia	2	2
Swelling/ Edema	2	2
Bruise/Contusion	1	1
Stomatitis	1	1
Respiratory Failure	1	1
Low Blood Pressure/ Hypotension	1	1
Death	1	1
Hypersensitivity/Allergic reaction	1	1
Apnea	1	1
Sore Throat	1	1
Wound Dehiscence	1	1
Infiltration into Tissue	1	1
Stacking Breaths	1	1
Respiratory Distress	1	1
Unspecified Respiratory Problem	1	1
Myocardial Hypertrophy	1	1
Bronchospasm	1	1
Forced Expiratory Volume Decreased	1	1