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
1. K193077 Shiley Adult Flexible Evac Tracheostomy Tube with ...
SMITHS MEDICAL ASD, INC.
	SUBSTANTIALLY EQUIVALENT	1
TRACOE MEDICAL GMBH
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Gas/Air Leak	1307	1316
Use of Device Problem	1231	1235
Inflation Problem	906	910
Material Split, Cut or Torn	481	482
Defective Component	424	425
Leak/Splash	300	301
Break	259	261
Disconnection	234	234
Connection Problem	215	216
Material Separation	126	126
Fluid/Blood Leak	119	119
Crack	117	117
Appropriate Term/Code Not Available	114	114
Defective Device	114	114
Material Puncture/Hole	99	99
Insufficient Information	91	91
Fracture	86	86
Physical Resistance/Sticking	80	81
Human-Device Interface Problem	76	76
Obstruction of Flow	65	67
Deflation Problem	59	61
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
Labelling, Instructions for Use or Training Problem	44	44
Contamination	44	44
Material Rupture	43	43
Patient Device Interaction Problem	42	42
Patient-Device Incompatibility	41	42
Material Discolored	40	40
Mechanical Problem	40	41
Material Integrity Problem	39	39
Component Missing	36	36
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
Adverse Event Without Identified Device or Use Problem	23	23
Device-Device Incompatibility	23	23
Deformation Due to Compressive Stress	22	22
Material Twisted/Bent	21	21
Fitting Problem	21	21
Loose or Intermittent Connection	18	18
Pressure Problem	18	18
Gel Leak	18	18

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3377	3389
Unintended Extubation	1613	1616
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
Airway Obstruction	58	58
Hemorrhage/Bleeding	58	58
Dyspnea	56	56
Respiratory Insufficiency	55	55
Discomfort	38	38
Hypoxia	28	28
Tachycardia	25	25
Cardiac Arrest	24	25
Pain	24	24
Skin Inflammation/ Irritation	24	24
Distress	20	20
Death	18	18
Aspiration/Inhalation	18	18
No Code Available	17	17
Respiratory Failure	16	16
Foreign Body In Patient	16	17
Unspecified Infection	15	16
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	14	14
Respiratory Distress	14	14
Pneumonia	13	13
Unspecified Respiratory Problem	13	13
Inflammation	13	13
Injury	11	11
Cough	11	11
Pressure Sores	11	11
Pneumothorax	11	11
Bradycardia	10	10
No Known Impact Or Consequence To Patient	10	10
Failure of Implant	9	9
Respiratory Tract Infection	8	8
Dysphasia	8	8
Anxiety	7	7
Stenosis	7	7
Bacterial Infection	7	7
Sore Throat	7	7
Obstruction/Occlusion	7	7
High Oxygen Saturation	7	7
Increased Respiratory Rate	6	6
Low Blood Pressure/ Hypotension	6	6