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
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	401	403
Inflation Problem	197	201
Leak/Splash	196	199
Break	161	163
Detachment of Device or Device Component	123	125
Crack	99	100
Disconnection	98	100
Defective Component	60	60
Material Split, Cut or Torn	58	58
Material Puncture/Hole	57	58
Fluid/Blood Leak	56	56
Material Separation	53	53
Connection Problem	46	46
Contamination /Decontamination Problem	45	45
Component Missing	43	43
Unintended Deflation	43	43
Device Markings/Labelling Problem	38	54
Fracture	37	37
Deflation Problem	32	32
Separation Problem	31	32
Defective Device	28	30
Obstruction of Flow	25	26
Incomplete or Missing Packaging	22	22
Use of Device Problem	21	21
Decrease in Pressure	20	20
Material Deformation	20	20
Nonstandard Device	20	20
Loose or Intermittent Connection	19	19
Fitting Problem	18	18
Pressure Problem	18	18
Device Damaged Prior to Use	18	18
Material Rupture	18	18
Suction Problem	16	16
Insufficient Information	16	16
Mechanical Problem	16	17
Tear, Rip or Hole in Device Packaging	15	15
Inadequacy of Device Shape and/or Size	14	14
Moisture or Humidity Problem	13	13
Device Dislodged or Dislocated	13	13
Difficult to Insert	13	13
Material Discolored	11	11
Patient Device Interaction Problem	11	12
Gel Leak	11	11
Complete Blockage	11	11
Degraded	10	10
Material Twisted/Bent	10	10
Material Fragmentation	9	9
Deformation Due to Compressive Stress	9	9
Physical Resistance/Sticking	8	8
Material Too Soft/Flexible	8	8

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1731	1747
Insufficient Information	227	228
No Consequences Or Impact To Patient	74	74
Low Oxygen Saturation	35	36
Decreased Respiratory Rate	29	29
Airway Obstruction	16	18
Extubate	13	13
Dyspnea	13	13
No Information	11	11
Unintended Extubation	10	10
Hypoxia	10	10
Hypoventilation	8	8
Respiratory Insufficiency	8	8
Aspiration/Inhalation	8	8
Aspiration Pneumonitis	7	7
Hemorrhage/Bleeding	6	6
Bradycardia	6	6
Cardiac Arrest	6	8
No Patient Involvement	5	7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
Pneumonia	4	4
Abrasion	3	3
Fistula	3	3
Fever	3	3
Skin Inflammation/ Irritation	2	2
Diminished Pulse Pressure	2	2
Device Embedded In Tissue or Plaque	2	2
Blister	2	2
Pneumothorax	2	2
Ventilator Dependent	2	2
Foreign Body In Patient	2	2
Chest Pain	2	2
Brain Injury	2	2
Pain	2	2
Failure of Implant	2	5
Swelling/ Edema	2	2
Distress	1	1
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
Apnea	1	1
Loss of consciousness	1	1
Bacterial Infection	1	1
Sore Throat	1	1
Wound Dehiscence	1	1
Infiltration into Tissue	1	1
Stacking Breaths	1	1