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
SMITHS MEDICAL ADS, INC.
	SUBSTANTIALLY EQUIVALENT	1
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	270	270
Leak/Splash	229	229
Inflation Problem	210	210
Break	152	152
Detachment of Device or Device Component	116	116
Crack	77	77
Disconnection	61	61
Defective Component	60	60
Connection Problem	57	57
Air Leak	52	52
Material Separation	48	48
Material Split, Cut or Torn	47	47
Component Missing	47	47
Contamination /Decontamination Problem	47	47
Fluid/Blood Leak	45	45
Material Puncture/Hole	44	44
Fracture	38	38
Device Markings/Labelling Problem	35	35
Separation Problem	32	32
Decrease in Pressure	28	28
Unintended Deflation	28	28
Defective Device	28	28
Deflation Problem	27	27
Obstruction of Flow	25	25
Material Integrity Problem	25	25
Material Deformation	23	23
Use of Device Problem	23	23
Inadequacy of Device Shape and/or Size	23	23
Device Damaged Prior to Use	22	22
Incomplete or Missing Packaging	22	22
Accessory Incompatible	20	20
Human-Device Interface Problem	20	20
Loose or Intermittent Connection	18	18
Insufficient Information	17	17
Mechanical Problem	16	16
Tear, Rip or Hole in Device Packaging	16	16
Material Discolored	15	15
Suction Problem	15	15
Material Rupture	14	14
Fitting Problem	13	13
Pressure Problem	12	12
Gel Leak	11	11
Patient Device Interaction Problem	10	10
Difficult to Insert	10	10
Difficult to Remove	10	10
Material Twisted/Bent	10	10
Moisture or Humidity Problem	10	10
Manufacturing, Packaging or Shipping Problem	9	9
Device Dislodged or Dislocated	9	9
Nonstandard Device	9	9

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1322	1322
No Consequences Or Impact To Patient	270	270
Insufficient Information	222	222
No Known Impact Or Consequence To Patient	66	66
No Information	38	39
Extubate	32	32
Low Oxygen Saturation	31	31
Decreased Respiratory Rate	29	29
Airway Obstruction	19	19
No Patient Involvement	15	15
Dyspnea	14	14
No Code Available	12	12
Hemorrhage/Bleeding	10	10
Aspiration/Inhalation	8	8
Unintended Extubation	8	8
Death	7	7
Discomfort	7	7
Foreign Body In Patient	7	7
Respiratory Insufficiency	7	7
Bradycardia	6	6
Hypoxia	6	6
Cardiac Arrest	6	6
Hypoventilation	6	6
Aspiration Pneumonitis	6	6
Pneumothorax	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Blood Loss	3	3
Abrasion	3	3
Respiratory Distress	3	3
Fistula	3	3
Apnea	3	3
Tissue Damage	3	3
Patient Problem/Medical Problem	3	3
Pain	3	3
Pneumonia	3	3
Ventricular Tachycardia	2	2
Skin Inflammation/ Irritation	2	2
Respiratory Failure	2	2
Ventilator Dependent	2	2
Laceration(s) of Esophagus	2	2
Brain Injury	2	2
Blister	2	2
Failure of Implant	2	2
Irritation	2	2
Ventricular Fibrillation	2	2
Pressure Sores	2	2
Fever	2	2
Swelling	2	2
Device Embedded In Tissue or Plaque	2	2
Chest Pain	2	2