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
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	1234	1234
Use of Device Problem	1129	1129
Inflation Problem	880	880
Material Split, Cut or Torn	443	443
Defective Component	416	416
Leak/Splash	288	288
Break	251	251
Disconnection	231	231
Connection Problem	214	214
Material Separation	122	122
Defective Device	113	113
Fluid/Blood Leak	112	112
Crack	111	111
Appropriate Term/Code Not Available	110	110
Insufficient Information	90	90
Material Puncture/Hole	89	89
Fracture	85	85
Physical Resistance/Sticking	78	78
Human-Device Interface Problem	72	72
Obstruction of Flow	61	61
Deflation Problem	59	59
Device Markings/Labelling Problem	54	54
Inadequacy of Device Shape and/or Size	49	49
Material Fragmentation	45	45
Labelling, Instructions for Use or Training Problem	44	44
Material Rupture	43	43
Patient Device Interaction Problem	42	42
Contamination	41	41
Patient-Device Incompatibility	41	41
Material Discolored	40	40
Detachment of Device or Device Component	38	38
Mechanical Problem	38	38
Material Integrity Problem	38	38
Component Missing	35	35
Unintended Deflation	33	33
Material Deformation	32	32
Difficult to Advance	30	30
No Apparent Adverse Event	30	30
Tear, Rip or Hole in Device Packaging	28	28
Product Quality Problem	27	27
Adverse Event Without Identified Device or Use Problem	23	23
Contamination /Decontamination Problem	23	23
Difficult to Insert	23	23
Deformation Due to Compressive Stress	22	22
Material Twisted/Bent	20	20
Device-Device Incompatibility	20	20
Fitting Problem	19	19
Gel Leak	18	18
Loose or Intermittent Connection	18	18
Microbial Contamination of Device	17	17

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3165	3165
Unintended Extubation	1541	1541
Insufficient Information	758	758
No Consequences Or Impact To Patient	450	450
Low Oxygen Saturation	164	164
Extubate	123	123
Hypoventilation	116	116
Decreased Respiratory Rate	82	82
No Patient Involvement	76	76
No Information	68	68
Airway Obstruction	59	59
Unspecified Tissue Injury	58	58
Hemorrhage/Bleeding	57	57
Dyspnea	55	55
Respiratory Insufficiency	51	51
Discomfort	35	35
Tachycardia	25	25
Hypoxia	25	25
Pain	24	24
Skin Inflammation/ Irritation	24	24
Cardiac Arrest	20	20
Distress	20	20
Death	18	18
Aspiration/Inhalation	18	18
No Code Available	17	17
Respiratory Failure	16	16
Foreign Body In Patient	15	15
Respiratory Distress	14	14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	14	14
Unspecified Respiratory Problem	13	13
Inflammation	13	13
Pneumonia	12	12
Cough	11	11
Pneumothorax	11	11
Injury	11	11
Unspecified Infection	11	11
Bradycardia	10	10
No Known Impact Or Consequence To Patient	10	10
Failure of Implant	9	9
Dysphasia	8	8
Respiratory Tract Infection	8	8
Pressure Sores	7	7
Bacterial Infection	7	7
Sore Throat	7	7
High Oxygen Saturation	7	7
Obstruction/Occlusion	7	7
Stenosis	6	6
Anxiety	6	6
Increased Respiratory Rate	6	6
Low Blood Pressure/ Hypotension	6	6