TPLC - Total Product Life Cycle

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Device	tube, tracheostomy (w/wo connector)
Product Code	BTO
Regulation Number	868.5800
Device Class	2

Premarket Reviews
Manufacturer	Decision
COOK, INC.
	SUBSTANTIALLY EQUIVALENT	1
PRIMED HALBERSTADT MEDIZINTECHNIK GMBH
	SUBSTANTIALLY EQUIVALENT	1
REGULATORY AND MARKETING SERVICES, INC.
	SUBSTANTIALLY EQUIVALENT	1
SMITHS MEDICAL ADS, INC.
	SUBSTANTIALLY EQUIVALENT	1
SMITHS MEDICAL ASD, INC.
	SUBSTANTIALLY EQUIVALENT	1
TELEFLEX MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
VENNER MEDICAL (SINGAPORE) PTE LTD
	SUBSTANTIALLY EQUIVALENT	2
VITALTEC CORPORATION
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Leak/Splash	318	318
Gas/Air Leak	270	270
Air Leak	239	239
Inflation Problem	235	235
Break	188	188
Detachment of Device or Device Component	118	118
Crack	100	100
Fracture	82	82
Connection Problem	64	64
Disconnection	62	62
Defective Component	61	61
Material Separation	53	53
Component Missing	49	49
Contamination /Decontamination Problem	47	47
Material Split, Cut or Torn	47	47
Fluid/Blood Leak	47	47
Material Puncture/Hole	44	44
Deflation Problem	40	40
Device Markings/Labelling Problem	36	36
Decrease in Pressure	35	35
Separation Problem	32	32
Defective Device	29	29
Unintended Deflation	28	28
Obstruction of Flow	27	27
Detachment Of Device Component	27	27
Material Deformation	26	26
Inadequacy of Device Shape and/or Size	26	26
Material Integrity Problem	26	26
Use of Device Problem	25	25
Device Damaged Prior to Use	23	23
Incomplete or Missing Packaging	23	23
Loose or Intermittent Connection	21	21
Human-Device Interface Problem	20	20
Accessory Incompatible	20	20
Material Rupture	19	19
Fitting Problem	18	18
Pressure Problem	18	18
Suction Problem	18	18
Insufficient Information	17	17
Mechanical Problem	16	16
Tear, Rip or Hole in Device Packaging	16	16
Material Discolored	15	15
Difficult to Insert	14	14
Adverse Event Without Identified Device or Use Problem	13	13
Device Dislodged or Dislocated	12	12
Device Operates Differently Than Expected	12	12
Difficult to Remove	12	12
Gel Leak	11	11
Material Twisted/Bent	11	11
Material Fragmentation	11	11

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1322	1322
No Consequences Or Impact To Patient	579	579
Insufficient Information	222	222
No Known Impact Or Consequence To Patient	144	144
Extubate	81	81
No Information	58	59
Low Oxygen Saturation	44	44
Therapy/non-surgical treatment, additional	31	31
Decreased Respiratory Rate	29	29
No Patient Involvement	27	27
Airway Obstruction	24	24
Dyspnea	16	16
No Code Available	16	16
Respiratory Distress	16	16
Hemorrhage/Bleeding	13	13
Death	12	12
Hypoxia	12	12
Foreign Body In Patient	10	10
Discomfort	9	9
Pneumothorax	8	8
Unintended Extubation	8	8
Aspiration/Inhalation	8	8
Bradycardia	8	8
Cardiac Arrest	7	7
Hypoventilation	7	7
Respiratory Insufficiency	7	7
Device Embedded In Tissue or Plaque	6	6
Aspiration Pneumonitis	6	6
Ventilator Dependent	5	5
Pain	5	5
Pressure Sores	4	4
Respiratory Failure	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Blood Loss	4	4
Patient Problem/Medical Problem	4	4
Tissue Damage	3	3
Pneumonia	3	3
Distress	3	3
Irritation	3	3
Fistula	3	3
Injury	3	3
Unspecified Infection	3	3
Cyanosis	3	3
Abrasion	3	3
Apnea	3	3
Blister	2	2
Ventricular Fibrillation	2	2
Fever	2	2
Laceration(s) of Esophagus	2	2
Swelling	2	2

Recalls
Manufacturer		Recall Class	Date Posted
1	Ambu Inc.	II	Mar-24-2016
2	Arcadia Medical Corporation	II	May-21-2012
3	Arcadia Medical Corporation	II	Jun-24-2011
4	Bryan Medical Inc	I	Jul-08-2013
5	Cardinal Health 200, LLC	I	Feb-16-2024
6	Gf Health Products, Inc.	II	Nov-09-2009
7	Instrumentation Industries Inc	II	Nov-12-2015
8	Instrumentation Industries Inc	II	Sep-03-2009
9	Nellcor Puritan Bennett Inc. (dba Covidien Ltd)	I	May-06-2010
10	Smiths Medical ASD Inc.	I	Sep-11-2024
11	Smiths Medical ASD Inc.	I	Aug-23-2024
12	Smiths Medical ASD Inc.	II	Jun-04-2019
13	Smiths Medical ASD Inc.	II	Jun-07-2018
14	Smiths Medical ASD, Inc.	I	Jan-19-2012
15	VBM Medical Inc.	II	Jun-28-2011