TPLC - Total Product Life Cycle

show TPLC since

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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Gas/Air Leak	308	308
Leak/Splash	178	178
Inflation Problem	178	178
Break	135	135
Detachment of Device or Device Component	112	112
Disconnection	80	80
Crack	76	76
Defective Component	58	58
Material Separation	50	50
Material Puncture/Hole	48	48
Material Split, Cut or Torn	46	46
Contamination /Decontamination Problem	45	45
Connection Problem	45	45
Fluid/Blood Leak	43	43
Component Missing	43	43
Unintended Deflation	39	39
Device Markings/Labelling Problem	37	37
Fracture	36	36
Separation Problem	31	31
Defective Device	28	28
Obstruction of Flow	24	24
Deflation Problem	23	23
Incomplete or Missing Packaging	22	22
Use of Device Problem	21	21
Material Deformation	19	19
Loose or Intermittent Connection	18	18
Decrease in Pressure	17	17
Fitting Problem	16	16
Device Damaged Prior to Use	16	16
Insufficient Information	16	16
Mechanical Problem	15	15
Tear, Rip or Hole in Device Packaging	15	15
Inadequacy of Device Shape and/or Size	14	14
Difficult to Insert	13	13
Material Rupture	12	12
Pressure Problem	12	12
Gel Leak	11	11
Suction Problem	11	11
Material Discolored	11	11
Moisture or Humidity Problem	10	10
Material Twisted/Bent	10	10
Patient Device Interaction Problem	10	10
Device Dislodged or Dislocated	9	9
Nonstandard Device	9	9
Material Fragmentation	9	9
Physical Resistance/Sticking	8	8
Material Too Soft/Flexible	8	8
Misconnection	7	7
Complete Blockage	7	7
Difficult to Remove	7	7

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1467	1467
Insufficient Information	223	223
No Consequences Or Impact To Patient	74	74
Low Oxygen Saturation	30	30
Decreased Respiratory Rate	29	29
Airway Obstruction	15	15
Extubate	13	13
No Information	11	11
Dyspnea	9	9
Unintended Extubation	8	8
Respiratory Insufficiency	8	8
Aspiration Pneumonitis	6	6
Bradycardia	6	6
Hemorrhage/Bleeding	5	5
No Patient Involvement	5	5
Cardiac Arrest	5	5
Hypoxia	4	4
Aspiration/Inhalation	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Hypoventilation	4	4
Abrasion	3	3
Fistula	3	3
Fever	3	3
Skin Inflammation/ Irritation	2	2
Device Embedded In Tissue or Plaque	2	2
Blister	2	2
Ventilator Dependent	2	2
Pneumothorax	2	2
Foreign Body In Patient	2	2
Chest Pain	2	2
Brain Injury	2	2
Failure of Implant	2	2
Pneumonia	2	2
Swelling/ Edema	2	2
Bruise/Contusion	1	1
Stomatitis	1	1
Respiratory Failure	1	1
Low Blood Pressure/ Hypotension	1	1
Death	1	1
Hypersensitivity/Allergic reaction	1	1
Sore Throat	1	1
Apnea	1	1
Infiltration into Tissue	1	1
Wound Dehiscence	1	1
Stacking Breaths	1	1
Respiratory Distress	1	1
Unspecified Respiratory Problem	1	1
Bronchospasm	1	1
Forced Expiratory Volume Decreased	1	1
Salivary Hypersecretion	1	1