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
1. K242921 5300600-5301000 Rota-Trach Disposable Standard Tra ...

Device Problems	MDRs with this Device Problem	Events in those MDRs
Gas/Air Leak	350	350
Inflation Problem	194	194
Leak/Splash	190	190
Break	156	156
Detachment of Device or Device Component	118	118
Disconnection	93	93
Crack	89	89
Connection Problem	65	65
Defective Component	58	58
Material Split, Cut or Torn	55	55
Material Puncture/Hole	52	52
Material Separation	51	51
Fluid/Blood Leak	48	48
Contamination /Decontamination Problem	47	47
Component Missing	43	43
Unintended Deflation	40	40
Device Markings/Labelling Problem	38	38
Fracture	37	37
Separation Problem	32	32
Deflation Problem	31	31
Defective Device	29	29
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
Loose or Intermittent Connection	19	19
Accessory Incompatible	19	19
Insufficient Information	17	17
Fitting Problem	16	16
Mechanical Problem	16	16
Inadequacy of Device Shape and/or Size	16	16
Device Damaged Prior to Use	16	16
Suction Problem	16	16
Material Discolored	15	15
Tear, Rip or Hole in Device Packaging	15	15
Pressure Problem	14	14
Material Rupture	13	13
Difficult to Insert	13	13
Material Integrity Problem	12	12
Moisture or Humidity Problem	11	11
Material Twisted/Bent	11	11
Gel Leak	11	11
Device Dislodged or Dislocated	10	10
Patient Device Interaction Problem	10	10
Material Fragmentation	9	9
Nonstandard Device	9	9
Physical Resistance/Sticking	9	9
Complete Blockage	8	8
Deformation Due to Compressive Stress	8	8

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1577	1577
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
No Information	19	19
Airway Obstruction	19	19
No Known Impact Or Consequence To Patient	13	13
Dyspnea	9	9
No Patient Involvement	8	8
Hypoxia	8	8
Unintended Extubation	8	8
Respiratory Insufficiency	8	8
Hypoventilation	7	7
Hemorrhage/Bleeding	7	7
Bradycardia	6	6
Aspiration Pneumonitis	6	6
No Code Available	5	5
Cardiac Arrest	5	5
Aspiration/Inhalation	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Fever	3	3
Foreign Body In Patient	3	3
Abrasion	3	3
Fistula	3	3
Death	3	3
Patient Problem/Medical Problem	3	3
Laceration(s) of Esophagus	2	2
Skin Inflammation/ Irritation	2	2
Respiratory Failure	2	2
Blister	2	2
Brain Injury	2	2
Ventilator Dependent	2	2
Failure of Implant	2	2
Device Embedded In Tissue or Plaque	2	2
Swelling/ Edema	2	2
Pneumothorax	2	2
Chest Pain	2	2
Pneumonia	2	2
Sore Throat	1	1
Infiltration into Tissue	1	1
Low Blood Pressure/ Hypotension	1	1
Stomatitis	1	1
Unspecified Respiratory Problem	1	1
Bronchospasm	1	1
Bruise/Contusion	1	1
Forced Expiratory Volume Decreased	1	1
Salivary Hypersecretion	1	1
Chemosis	1	1