Tube Tracheostomy And Tube Cuff

Device Code: 136

Product Code(s): JOH

Device Classification Information

• Device Type ID: 136
• Device Name: Tube Tracheostomy And Tube Cuff
• Regulation Description: Tracheostomy Tube And Tube Cuff.
• Regulation Medical Specialty: Anesthesiology
• Review Panel: Anesthesiology
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID); Anesthesiology Devices Branch (ANDB)
• Submission Type: 510(k)
• CFR Regulation Number: 868.5800 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: JOH
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: Yes
• Third Party Review: Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

• 1-62 ISO 5356-1 Third Edition 2004-05-15
  Anaesthetic And Respiratory Equipment - Conical Connectors: Part 1: Cones And Sockets
• 1-117 ISO 5366 First Edition 2016-10-01
  Anaesthetic And Respiratory Equipment - Tracheostomy Tubes And Connectors
• 1-120 ISO 18190 First Edition 2016-11-01
  Anaesthetic And Respiratory Equipment - General Requirements For Airways And Related Equipment
• 1-134 ISO 18562-1 First Edition 2017-03
  Biocompatibility Evaluation Of Breathing Gas Pathways In Healthcare Applications - Part 1: Evaluation And Testing Within A Risk Management Process
• 1-135 ISO 18562-2 First Edition 2017-03
  Biocompatibility Evaluation Of Breathing Gas Pathways In Healthcare Applications - Part 2: Tests For Emissions Of Particulate Matter
• 1-136 ISO 18562-3 First Edition 2017-03
  Biocompatibility Evaluation Of Breathing Gas Pathways In Healthcare Applications - Part 3: Tests For Emissions Of Volatile Organic Compounds
• 1-137 ISO 18562-4 First Edition 2017-03
  Biocompatibility Evaluation Of Breathing Gas Pathways In Healthcare Applications - Part 4: Tests For Leachables In Condensate

Total Product Life Cycle

• Device Type ID: 136
• Device: Tube Tracheostomy And Tube Cuff
• Product Code: JOH
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Tracheostomy Tube And Tube Cuff.
• CFR Regulation Number: 868.5800 [🔎]

Premarket Reviews
Manufacturer	Decision
ATOS MEDICAL AB
	SUBSTANTIALLY EQUIVALENT	1
COOK, INC.
	SUBSTANTIALLY EQUIVALENT	2
COVIDIEN
	SUBSTANTIALLY EQUIVALENT	4
H&H MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
SMITHS
	SUBSTANTIALLY EQUIVALENT	2
SMITHS GROUP PLC
	SUBSTANTIALLY EQUIVALENT	2
TELEFLEX MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
TELEFLEX MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
TRACOE MEDICAL GMBH
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Cuff	526
Leak / Splash	348
Inflation Problem	333
Tube	199
Air Leak	185
Fluid Leak	184
Break	160
Flange	116
Fracture	88
Material Integrity Problem	73
Connector	64
Hole In Material	60
Material Deformation	58
Balloon	53
Eyelet	50
Crack	50
Inadequacy Of Device Shape And/or Size	47
Split	44
Connection Problem	43
Material Split, Cut Or Torn	42
Material Rupture	39
Material Discolored	37
Human-Device Interface Problem	36
Fitting Problem	35
Product Quality Problem	30
Detachment Of Device Component	29
Deflation Problem	28
Cannula	28
Adverse Event Without Identified Device Or Use Problem	27
Disconnection	27
Defective Device	26
Output Problem	25
Burst Container Or Vessel	25
Defective Component	24
Material Separation	23
Failure To Disconnect	22
Detachment Of Device Or Device Component	20
Device Markings / Labelling Problem	19
Pilot Balloon Valve	19
Torn Material	18
Occlusion Within Device	18
Obstruction Of Flow	18
Material Puncture / Hole	17
Manufacturing, Packaging Or Shipping Problem	17
Cut In Material	16
Device Dislodged Or Dislocated	16
Gas Leak	16
Component(s), Broken	15
Insufficient Information	14
Difficult To Remove	14
Cannula, Inner	14
Material Perforation	13
Mechanical Problem	12
Positioning Problem	12
Wire	12
Shaft	11
Suction Problem	11
Kinked	11
Loose Or Intermittent Connection	11
Material Fragmentation	11
Component Missing	10
Patient-Device Incompatibility	10
Device Operates Differently Than Expected	10
Partial Blockage	9
Noise, Audible	9
Naturally Worn	9
Device Alarm System	8
Sticking	8
Decrease In Pressure	8
Material Protrusion / Extrusion	7
System	7
Sharp Edges	7
Difficult To Insert	7
Packaging Problem	7
Difficult To Position	7
Cannula, Outer	7
Adapter (Adaptor)	7
Infusion Or Flow Problem	7
Catheter	7
Tear, Rip Or Hole In Device Packaging	6
Suction Failure	6
Failure To Align	6
Adhesive	6
Pressure Problem	6
Contamination Of Device Ingredient Or Reagent	5
Collapse	5
Obturator	5
Optical Discoloration	5
Device Component Or Accessory	5
Physical Property Issue	5
Deformation Due To Compressive Stress	5
Loss Of Or Failure To Bond	5
Contamination / Decontamination Problem	5
Label	4
Degraded	4
Device Operational Issue	4
Port	4
Device Slipped	4
Needle	4
Scratched Material	4
Total Device Problems	3793

Recalls
Manufacturer		Recall Class	Date Posted
1	Covidien LP (formerly Nellcor Puritan Bennett Inc.)	I	Jul-09-2015
2	Smiths Medical ASD Inc.	II	Sep-26-2017
3	Smiths Medical ASD Inc.	II	Mar-14-2017
4	Smiths Medical ASD, Inc.	II	Feb-09-2018
5	Teleflex Medical	I	Oct-18-2016

TPLC Last Update: 2019-04-02 19:29:33