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	342	342
Inflation Problem	192	192
Leak/Splash	188	188
Break	155	155
Detachment of Device or Device Component	118	118
Disconnection	91	91
Crack	85	85
Connection Problem	65	65
Defective Component	58	58
Material Split, Cut or Torn	54	54
Material Separation	51	51
Material Puncture/Hole	49	49
Contamination /Decontamination Problem	47	47
Fluid/Blood Leak	46	46
Component Missing	43	43
Unintended Deflation	40	40
Device Markings/Labelling Problem	38	38
Fracture	37	37
Separation Problem	32	32
Defective Device	29	29
Deflation Problem	28	28
Obstruction of Flow	25	25
Use of Device Problem	23	23
Incomplete or Missing Packaging	22	22
Decrease in Pressure	22	22
Material Deformation	21	21
Accessory Incompatible	19	19
Loose or Intermittent Connection	19	19
Insufficient Information	17	17
Mechanical Problem	16	16
Suction Problem	16	16
Fitting Problem	16	16
Device Damaged Prior to Use	16	16
Inadequacy of Device Shape and/or Size	16	16
Material Discolored	15	15
Tear, Rip or Hole in Device Packaging	15	15
Pressure Problem	14	14
Difficult to Insert	13	13
Material Rupture	13	13
Material Integrity Problem	11	11
Moisture or Humidity Problem	11	11
Gel Leak	11	11
Material Twisted/Bent	11	11
Device Dislodged or Dislocated	10	10
Patient Device Interaction Problem	10	10
Physical Resistance/Sticking	9	9
Nonstandard Device	9	9
Material Fragmentation	9	9
Deformation Due to Compressive Stress	8	8
Complete Blockage	8	8

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1554	1554
Insufficient Information	224	224
No Consequences Or Impact To Patient	115	115
Low Oxygen Saturation	32	32
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
Hypoxia	8	8
Respiratory Insufficiency	8	8
Unintended Extubation	8	8
Hypoventilation	7	7
Hemorrhage/Bleeding	7	7
Bradycardia	6	6
Aspiration Pneumonitis	6	6
Cardiac Arrest	5	5
No Code Available	5	5
Aspiration/Inhalation	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Abrasion	3	3
Fistula	3	3
Fever	3	3
Foreign Body In Patient	3	3
Death	3	3
Patient Problem/Medical Problem	3	3
Respiratory Failure	2	2
Skin Inflammation/ Irritation	2	2
Ventilator Dependent	2	2
Laceration(s) of Esophagus	2	2
Blister	2	2
Brain Injury	2	2
Failure of Implant	2	2
Device Embedded In Tissue or Plaque	2	2
Pneumothorax	2	2
Chest Pain	2	2
Swelling/ Edema	2	2
Pneumonia	2	2
Low Blood Pressure/ Hypotension	1	1
Sore Throat	1	1
Infiltration into Tissue	1	1
Stomatitis	1	1
Unspecified Respiratory Problem	1	1
Salivary Hypersecretion	1	1
Bruise/Contusion	1	1
Bronchospasm	1	1
Forced Expiratory Volume Decreased	1	1
Chemosis	1	1