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	370	371
Inflation Problem	194	196
Leak/Splash	193	193
Break	149	149
Detachment of Device or Device Component	120	120
Crack	95	95
Disconnection	94	94
Defective Component	59	59
Material Puncture/Hole	55	56
Material Split, Cut or Torn	54	54
Material Separation	52	52
Fluid/Blood Leak	49	49
Contamination /Decontamination Problem	45	45
Connection Problem	45	45
Component Missing	43	43
Unintended Deflation	42	42
Fracture	37	37
Device Markings/Labelling Problem	37	53
Deflation Problem	31	31
Separation Problem	31	31
Defective Device	28	28
Obstruction of Flow	25	25
Incomplete or Missing Packaging	22	22
Use of Device Problem	21	21
Material Deformation	20	20
Nonstandard Device	20	20
Decrease in Pressure	20	20
Loose or Intermittent Connection	19	19
Pressure Problem	18	18
Fitting Problem	18	18
Device Damaged Prior to Use	17	17
Material Rupture	16	16
Suction Problem	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
Difficult to Insert	13	13
Moisture or Humidity Problem	12	12
Device Dislodged or Dislocated	12	12
Material Discolored	11	11
Gel Leak	11	11
Patient Device Interaction Problem	10	10
Material Twisted/Bent	10	10
Material Fragmentation	9	9
Deformation Due to Compressive Stress	9	9
Complete Blockage	8	8
Degraded	8	8
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	1651	1652
Insufficient Information	227	227
No Consequences Or Impact To Patient	74	74
Low Oxygen Saturation	33	33
Decreased Respiratory Rate	29	29
Airway Obstruction	15	15
Extubate	13	13
No Information	11	11
Unintended Extubation	9	9
Dyspnea	9	9
Hypoventilation	8	8
Respiratory Insufficiency	8	8
Aspiration Pneumonitis	7	7
Hypoxia	7	7
Aspiration/Inhalation	7	7
Hemorrhage/Bleeding	6	6
Bradycardia	6	6
Cardiac Arrest	6	8
No Patient Involvement	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Pneumonia	4	4
Fistula	3	3
Abrasion	3	3
Fever	3	3
Device Embedded In Tissue or Plaque	2	2
Ventilator Dependent	2	2
Swelling/ Edema	2	2
Chest Pain	2	2
Foreign Body In Patient	2	2
Pneumothorax	2	2
Blister	2	2
Failure of Implant	2	5
Brain Injury	2	2
Diminished Pulse Pressure	2	2
Skin Inflammation/ Irritation	2	2
Bruise/Contusion	1	1
Wound Dehiscence	1	1
Stacking Breaths	1	1
Stomatitis	1	1
Respiratory Failure	1	1
Low Blood Pressure/ Hypotension	1	1
Apnea	1	1
Death	1	1
Hypersensitivity/Allergic reaction	1	1
Decreased Sensitivity	1	1
Sore Throat	1	1
Infiltration into Tissue	1	1
Bacterial Infection	1	1
Adult Respiratory Distress Syndrome	1	1
Respiratory Distress	1	1