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	384	386
Leak/Splash	204	207
Inflation Problem	201	205
Break	164	166
Detachment of Device or Device Component	123	125
Disconnection	98	100
Crack	97	98
Connection Problem	66	66
Material Split, Cut or Torn	62	62
Defective Component	60	60
Material Puncture/Hole	57	58
Material Separation	53	53
Fluid/Blood Leak	52	52
Contamination /Decontamination Problem	47	47
Component Missing	43	43
Unintended Deflation	42	42
Device Markings/Labelling Problem	39	55
Fracture	37	37
Deflation Problem	36	36
Separation Problem	32	33
Defective Device	29	31
Obstruction of Flow	25	26
Use of Device Problem	23	23
Decrease in Pressure	22	22
Incomplete or Missing Packaging	22	22
Material Deformation	21	21
Nonstandard Device	20	20
Loose or Intermittent Connection	19	19
Accessory Incompatible	19	19
Fitting Problem	18	18
Pressure Problem	18	18
Device Damaged Prior to Use	17	17
Insufficient Information	17	17
Material Rupture	16	16
Inadequacy of Device Shape and/or Size	16	16
Suction Problem	16	16
Mechanical Problem	16	17
Material Discolored	15	15
Tear, Rip or Hole in Device Packaging	15	15
Material Integrity Problem	14	14
Moisture or Humidity Problem	13	13
Device Dislodged or Dislocated	13	13
Difficult to Insert	13	13
Gel Leak	11	11
Material Twisted/Bent	11	11
Patient Device Interaction Problem	10	11
Degraded	10	10
Deformation Due to Compressive Stress	9	9
Physical Resistance/Sticking	9	9
Material Fragmentation	9	9

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1683	1699
Insufficient Information	227	228
No Consequences Or Impact To Patient	115	115
Low Oxygen Saturation	36	37
Decreased Respiratory Rate	29	29
Extubate	20	20
No Information	19	19
Airway Obstruction	19	21
No Known Impact Or Consequence To Patient	13	29
Unintended Extubation	10	10
Dyspnea	9	9
Hypoventilation	9	9
No Patient Involvement	8	10
Hypoxia	8	8
Respiratory Insufficiency	8	8
Aspiration Pneumonitis	7	7
Hemorrhage/Bleeding	7	7
Aspiration/Inhalation	7	7
Bradycardia	6	6
Cardiac Arrest	6	8
No Code Available	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Pneumonia	4	4
Foreign Body In Patient	3	3
Fever	3	3
Abrasion	3	3
Fistula	3	3
Death	3	3
Patient Problem/Medical Problem	3	3
Laceration(s) of Esophagus	2	2
Blister	2	2
Diminished Pulse Pressure	2	2
Skin Inflammation/ Irritation	2	2
Ventilator Dependent	2	2
Respiratory Failure	2	2
Brain Injury	2	2
Failure of Implant	2	5
Chest Pain	2	2
Device Embedded In Tissue or Plaque	2	2
Pneumothorax	2	2
Swelling/ Edema	2	2
Loss of consciousness	1	1
Sore Throat	1	1
Infiltration into Tissue	1	1
Bacterial Infection	1	1
Low Blood Pressure/ Hypotension	1	1
Stomatitis	1	1
Unspecified Respiratory Problem	1	1
Salivary Hypersecretion	1	1
Bronchospasm	1	1