TPLC - Total Product Life Cycle

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Device	tube, tracheostomy (w/wo connector)
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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Gas/Air Leak	265	265
Leak/Splash	186	186
Inflation Problem	182	182
Break	136	136
Detachment of Device or Device Component	113	113
Crack	70	70
Disconnection	59	59
Defective Component	57	57
Connection Problem	55	55
Material Separation	48	48
Contamination /Decontamination Problem	47	47
Material Split, Cut or Torn	45	45
Component Missing	43	43
Material Puncture/Hole	43	43
Fluid/Blood Leak	41	41
Device Markings/Labelling Problem	35	35
Fracture	34	34
Separation Problem	32	32
Unintended Deflation	28	28
Defective Device	26	26
Obstruction of Flow	24	24
Use of Device Problem	23	23
Incomplete or Missing Packaging	22	22
Deflation Problem	21	21
Material Deformation	20	20
Accessory Incompatible	19	19
Loose or Intermittent Connection	17	17
Decrease in Pressure	17	17
Insufficient Information	17	17
Inadequacy of Device Shape and/or Size	16	16
Device Damaged Prior to Use	16	16
Tear, Rip or Hole in Device Packaging	15	15
Material Discolored	15	15
Mechanical Problem	13	13
Pressure Problem	12	12
Gel Leak	11	11
Fitting Problem	11	11
Suction Problem	11	11
Material Integrity Problem	11	11
Moisture or Humidity Problem	10	10
Material Twisted/Bent	10	10
Patient Device Interaction Problem	10	10
Nonstandard Device	9	9
Material Fragmentation	9	9
Material Rupture	9	9
Difficult to Insert	9	9
Physical Resistance/Sticking	8	8
Device Dislodged or Dislocated	8	8
Difficult to Remove	8	8
Deformation Due to Compressive Stress	7	7

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1322	1322
Insufficient Information	222	222
No Consequences Or Impact To Patient	115	115
Low Oxygen Saturation	29	29
Decreased Respiratory Rate	29	29
Extubate	20	20
Airway Obstruction	19	19
No Information	19	19
No Known Impact Or Consequence To Patient	13	13
Dyspnea	9	9
No Patient Involvement	8	8
Unintended Extubation	8	8
Respiratory Insufficiency	7	7
Aspiration Pneumonitis	6	6
Hemorrhage/Bleeding	6	6
Cardiac Arrest	5	5
Bradycardia	5	5
No Code Available	5	5
Hypoxia	5	5
Hypoventilation	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Aspiration/Inhalation	4	4
Fistula	3	3
Patient Problem/Medical Problem	3	3
Abrasion	3	3
Death	3	3
Foreign Body In Patient	3	3
Fever	2	2
Respiratory Failure	2	2
Blister	2	2
Brain Injury	2	2
Failure of Implant	2	2
Skin Inflammation/ Irritation	2	2
Pneumonia	2	2
Swelling/ Edema	2	2
Chest Pain	2	2
Ventilator Dependent	2	2
Device Embedded In Tissue or Plaque	2	2
Laceration(s) of Esophagus	2	2
Pneumothorax	2	2
Chemosis	1	1
Wound Dehiscence	1	1
Bruise/Contusion	1	1
Stacking Breaths	1	1
Hypersensitivity/Allergic reaction	1	1
Perforation	1	1
Obstruction/Occlusion	1	1
Pain	1	1
Myocardial Hypertrophy	1	1
Stomatitis	1	1