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
1. K192511 Venner PneuX™ TT (Tracheostomy Tube) Size 7.0 mm, ...

Device Problems	MDRs with this Device Problem	Events in those MDRs
Gas/Air Leak	281	281
Leak/Splash	186	186
Inflation Problem	183	183
Break	140	140
Detachment of Device or Device Component	113	113
Disconnection	74	74
Crack	72	72
Connection Problem	61	61
Defective Component	57	57
Material Separation	48	48
Contamination /Decontamination Problem	47	47
Material Split, Cut or Torn	46	46
Material Puncture/Hole	43	43
Component Missing	43	43
Fluid/Blood Leak	42	42
Device Markings/Labelling Problem	38	38
Fracture	35	35
Separation Problem	32	32
Unintended Deflation	28	28
Defective Device	28	28
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
Device Damaged Prior to Use	16	16
Inadequacy of Device Shape and/or Size	16	16
Tear, Rip or Hole in Device Packaging	15	15
Material Discolored	15	15
Mechanical Problem	14	14
Fitting Problem	12	12
Pressure Problem	12	12
Material Integrity Problem	11	11
Suction Problem	11	11
Gel Leak	11	11
Difficult to Insert	10	10
Material Rupture	10	10
Material Twisted/Bent	10	10
Moisture or Humidity Problem	10	10
Patient Device Interaction Problem	10	10
Device Dislodged or Dislocated	9	9
Material Fragmentation	9	9
Nonstandard Device	9	9
Difficult to Remove	8	8
Physical Resistance/Sticking	8	8
Material Too Soft/Flexible	7	7

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1379	1379
Insufficient Information	222	222
No Consequences Or Impact To Patient	115	115
Decreased Respiratory Rate	29	29
Low Oxygen Saturation	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
Hemorrhage/Bleeding	6	6
Aspiration Pneumonitis	6	6
Bradycardia	5	5
Hypoxia	5	5
Cardiac Arrest	5	5
No Code Available	5	5
Hypoventilation	5	5
Aspiration/Inhalation	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Abrasion	3	3
Fistula	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
Fever	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
Salivary Hypersecretion	1	1
Bruise/Contusion	1	1
Forced Expiratory Volume Decreased	1	1
Chemosis	1	1
Hematemesis	1	1
Pain	1	1