Catheters, Suction, Tracheobronchial

Device Code: 13

Product Code(s): BSY

Device Type ID	13
Device Name	Catheters, Suction, Tracheobronchial
Regulation Description	Tracheobronchial Suction Catheter.
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) Respiratory Devices Branch (RPDB)
Submission Type	510(K) Exempt
CFR Regulation Number	868.6810 [🔎]
FDA Device Classification	Class 1 Medical Device
Product Code	BSY
GMP Exempt	No
Summary MR	Eligible
Implanted Device	No
Life Support Device	No
Third Party Review	Not Third Party Eligible

Device Type ID	13
Device	Catheters, Suction, Tracheobronchial
Product Code	BSY
FDA Device Classification	Class 1 Medical Device
Regulation Description	Tracheobronchial Suction Catheter.
CFR Regulation Number	868.6810 [🔎]

Device Problems
Disconnection	663
Device Operates Differently Than Expected	142
Break	53
Air Leak	37
Nonstandard Device	36
Fitting Problem	26
Detachment Of Device Or Device Component	22
Leak / Splash	19
Loose Or Intermittent Connection	13
Detachment Of Device Component	12
Sticking	11
Suction Problem	10
Catheter	7
Adverse Event Without Identified Device Or Use Problem	7
Gas Leak	6
Device Contamination With Chemical Or Other Material	5
Material Fragmentation	5
Crack	5
Fluid Leak	4
Device Dislodged Or Dislocated	4
Incorrect Measurement	4
Inadequate Instructions For Healthcare Professional	3
Delivered As Unsterile Product	3
Connection Problem	3
Bent	3
Inflation Problem	3
Decrease In Suction	3
Device Issue	3
Physical Resistance / Sticking	3
Partial Blockage	2
Human Factors Issue	2
Material Separation	2
Material Rupture	2
Split	2
Y-Piece Connector	2
Improper Or Incorrect Procedure Or Method	2
Occlusion Within Device	2
Cannula	2
Deflation Problem	2
Retraction Problem	2
Use Of Device Problem	2
Difficult To Open Or Close	2
Component Missing	1
Obstruction Of Flow	1
Appropriate Term/Code Not Available	1
Component Misassembled	1
Extrusion	1
Suction Failure	1
Failure To Adhere Or Bond	1
Valve	1
Migration Or Expulsion Of Device	1
Fracture	1
Mechanical Problem	1
Packaging Problem	1
Noise, Audible	1
Device Slipped	1
Failure To Disconnect	1
Malposition Of Device	1
Spring	1
Unsealed Device Packaging	1
Device Handling Problem	1
Control Switches	1
Device Contaminated During Manufacture Or Shipping	1
Material Deformation	1
Total Device Problems	1163

TPLC Last Update: 2019-04-02 19:26:42