TPLC - Total Product Life Cycle

show TPLC since

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
1. K233713 Pilling Tracheostomy Tubes
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	370	371
Leak/Splash	202	202
Inflation Problem	200	202
Break	161	161
Detachment of Device or Device Component	122	122
Crack	97	97
Disconnection	96	96
Connection Problem	65	65
Material Split, Cut or Torn	59	59
Defective Component	59	59
Material Puncture/Hole	56	57
Material Separation	53	53
Fluid/Blood Leak	49	49
Contamination /Decontamination Problem	47	47
Component Missing	43	43
Unintended Deflation	42	42
Device Markings/Labelling Problem	38	54
Fracture	37	37
Deflation Problem	35	35
Separation Problem	32	32
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
Nonstandard Device	20	20
Loose or Intermittent Connection	19	19
Accessory Incompatible	19	19
Pressure Problem	18	18
Fitting Problem	18	18
Device Damaged Prior to Use	17	17
Insufficient Information	17	17
Material Rupture	16	16
Suction Problem	16	16
Mechanical Problem	16	16
Inadequacy of Device Shape and/or Size	16	16
Tear, Rip or Hole in Device Packaging	15	15
Material Discolored	15	15
Material Integrity Problem	14	14
Device Dislodged or Dislocated	13	13
Difficult to Insert	13	13
Moisture or Humidity Problem	12	12
Gel Leak	11	11
Material Twisted/Bent	11	11
Patient Device Interaction Problem	10	10
Physical Resistance/Sticking	9	9
Deformation Due to Compressive Stress	9	9
Material Fragmentation	9	9
Complete Blockage	8	8

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1651	1652
Insufficient Information	227	227
No Consequences Or Impact To Patient	115	115
Low Oxygen Saturation	35	35
Decreased Respiratory Rate	29	29
Extubate	20	20
Airway Obstruction	19	19
No Information	19	19
No Known Impact Or Consequence To Patient	13	29
Hypoventilation	9	9
Unintended Extubation	9	9
Dyspnea	9	9
Respiratory Insufficiency	8	8
Hypoxia	8	8
No Patient Involvement	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
Patient Problem/Medical Problem	3	3
Death	3	3
Fistula	3	3
Abrasion	3	3
Foreign Body In Patient	3	3
Fever	3	3
Device Embedded In Tissue or Plaque	2	2
Respiratory Failure	2	2
Ventilator Dependent	2	2
Swelling/ Edema	2	2
Chest Pain	2	2
Pneumothorax	2	2
Blister	2	2
Laceration(s) of Esophagus	2	2
Failure of Implant	2	5
Brain Injury	2	2
Diminished Pulse Pressure	2	2
Skin Inflammation/ Irritation	2	2
Bruise/Contusion	1	1
Hypovolemic Shock	1	1
Wound Dehiscence	1	1
Stomatitis	1	1
Low Blood Pressure/ Hypotension	1	1
Stacking Breaths	1	1
Apnea	1	1
Hypersensitivity/Allergic reaction	1	1
Decreased Sensitivity	1	1