TPLC - Total Product Life Cycle

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Device	tube tracheostomy and tube cuff
Regulation Description	Tracheostomy tube and tube cuff.
Product Code	JOH
Regulation Number	868.5800
Device Class	2

Premarket Reviews
Manufacturer	Decision
COVIDIEN
	SUBSTANTIALLY EQUIVALENT	1
COVIDIEN, LLC
	SUBSTANTIALLY EQUIVALENT	1
SMITHS MEDICAL ASD, INC.
	SUBSTANTIALLY EQUIVALENT	1
1. K210833 Portex BLUxl Extra Length Tracheostomy Tube, BLUxl ...
TRACOE MEDICAL GMBH
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Gas/Air Leak	1325	1334
Use of Device Problem	1244	1248
Inflation Problem	909	913
Material Split, Cut or Torn	492	493
Defective Component	426	427
Leak/Splash	303	304
Break	260	262
Disconnection	236	236
Connection Problem	215	216
Material Separation	126	126
Fluid/Blood Leak	119	119
Crack	118	118
Appropriate Term/Code Not Available	115	115
Defective Device	114	114
Material Puncture/Hole	101	101
Insufficient Information	91	91
Fracture	87	87
Physical Resistance/Sticking	80	81
Human-Device Interface Problem	76	76
Obstruction of Flow	66	68
Deflation Problem	60	62
Device Markings/Labelling Problem	54	54
Detachment of Device or Device Component	54	54
Inadequacy of Device Shape and/or Size	49	49
Material Fragmentation	45	46
Material Rupture	44	44
Labelling, Instructions for Use or Training Problem	44	44
Contamination	44	44
Patient Device Interaction Problem	42	42
Patient-Device Incompatibility	41	42
Mechanical Problem	40	41
Material Discolored	40	40
Material Integrity Problem	39	39
Component Missing	37	37
Unintended Deflation	34	34
Material Deformation	33	33
Difficult to Advance	33	33
No Apparent Adverse Event	30	30
Tear, Rip or Hole in Device Packaging	29	29
Product Quality Problem	28	30
Difficult to Insert	24	24
Contamination /Decontamination Problem	24	24
Device-Device Incompatibility	23	23
Adverse Event Without Identified Device or Use Problem	23	23
Deformation Due to Compressive Stress	22	22
Material Twisted/Bent	21	21
Fitting Problem	21	21
Pressure Problem	19	19
Loose or Intermittent Connection	18	18
Gel Leak	18	18

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3415	3427
Unintended Extubation	1638	1641
Insufficient Information	778	785
No Consequences Or Impact To Patient	450	450
Low Oxygen Saturation	168	168
Extubate	123	123
Hypoventilation	122	122
Decreased Respiratory Rate	82	82
No Patient Involvement	76	76
No Information	68	68
Unspecified Tissue Injury	62	63
Hemorrhage/Bleeding	59	59
Airway Obstruction	58	58
Dyspnea	57	57
Respiratory Insufficiency	55	55
Discomfort	40	40
Hypoxia	29	29
Tachycardia	25	25
Cardiac Arrest	25	26
Pain	24	24
Skin Inflammation/ Irritation	24	24
Distress	20	20
Aspiration/Inhalation	19	19
Death	18	18
No Code Available	17	17
Foreign Body In Patient	16	17
Respiratory Failure	16	16
Unspecified Infection	15	16
Inflammation	14	14
Respiratory Distress	14	14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	14	14
Unspecified Respiratory Problem	13	13
Pneumonia	13	13
Pressure Sores	11	11
Pneumothorax	11	11
Injury	11	11
Bradycardia	11	11
Cough	11	11
No Known Impact Or Consequence To Patient	10	10
Failure of Implant	9	9
Dysphasia	8	8
Respiratory Tract Infection	8	8
Sore Throat	7	7
Bacterial Infection	7	7
High Oxygen Saturation	7	7
Obstruction/Occlusion	7	7
Anxiety	7	7
Stenosis	7	7
Irritation	6	6
Increased Respiratory Rate	6	6