TPLC - Total Product Life Cycle

• Device: tube, tracheal (w/wo connector)
• Regulation Description: Tracheal tube.
• Product Code: BTR
• Regulation Number: 868.5730
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
COOK, INC.
	SUBSTANTIALLY EQUIVALENT	1
COVIDIEN
	SUBSTANTIALLY EQUIVALENT	1
DAVIS MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
ETVIEW LTD.
	SUBSTANTIALLY EQUIVALENT	2
TELEFLEX MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
TELEFLEX MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
TIANJIN MEDIS MEDICAL DEVICE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
WILLIAM COOK
	SUBSTANTIALLY EQUIVALENT	1
WILLIAM COOK EUROPE APS
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Inflation Problem	876
Leak / Splash	426
Cuff	220
Gas Leak	208
Air Leak	206
Disconnection	203
Device Contamination with Chemical or Other Material	199
Use of Device Problem	158
Detachment of Device or device Component	145
Defective Component	125
Device Markings / Labelling Problem	108
Tube	99
Deflation Problem	96
Break	94
Connection Problem	82
Material Deformation	76
Loose or Intermittent Connection	71
Device Operates Differently Than Expected	67
Material Separation	61
Kinked	60
Detachment Of Device Component	47
Material Split, Cut or Torn	46
Material Puncture / Hole	43
Occlusion Within Device	40
Obstruction of Flow	39
Insufficient Information	37
Human-Device Interface Problem	36
Pressure Problem	36
Appropriate Term/Code Not Available	35
Material Rupture	35
Material Integrity Problem	33
Contamination / decontamination Problem	33
Partial Blockage	32
Balloon	30
Contamination During Use	29
Adverse Event Without Identified Device or Use Problem	27
Device Packaging Compromised	27
Burst Container or Vessel	26
Fitting Problem	26
Contamination of Device Ingredient or Reagent	25
Crack	23
Inadequate Instructions for Healthcare Professional	22
Deformation Due to Compressive Stress	21
Difficult to Advance	21
Hole In Material	21
Connector	19
Packaging Problem	18
Bent	17
Fracture	17
Component Missing	16
Pilot Balloon Valve	16
Inadequacy of Device Shape and/or Size	16
Malposition of device	15
Decrease in Pressure	15
Material Too Rigid or Stiff	14
Defective Device	13
Torn Material	13
Device Damaged Prior to Use	13
Material Fragmentation	11
Failure to Disconnect	11
Mechanical Problem	10
Delivered as Unsterile Product	10
Tear, Rip or Hole in Device Packaging	10
Fluid Leak	10
Material Twisted / Bent	10
Difficult to Insert	10
Unsealed Device Packaging	10
Product Quality Problem	9
Device Alarm System	9
Peeled / Delaminated	8
Split	8
Ejection Problem	8
Flange	8
System	8
Material Perforation	7
Device Dislodged or Dislocated	7
Unraveled Material	6
Cannula	6
Manufacturing, Packaging or Shipping Problem	5
Delamination	5
Valve	5
Physical Resistance	5
Cut In Material	4
Patient Device Interaction Problem	4
False Alarm	4
Stylet	4
Nonstandard device	4
Separation Failure	4
Infusion or Flow Problem	4
Device-Device Incompatibility	4
Off-Label Use	4
Suction Problem	4
Collapse	3
Output Problem	3
Alarm	3
Device Operational Issue	3
Joint	3
Probe	3
Material Protrusion / Extrusion	3
Ventilation Problem in Device Environment	3
Total Device Problems	4832

Recalls
Manufacturer		Recall Class	Date Posted
1	Centurion Medical Products Corporation	I	Jul-30-2019
2	Parker Medical	II	Jul-19-2016
3	Stryker Sustainability Solutions	II	May-09-2016
4	Teleflex Medical	I	Sep-09-2019
5	Teleflex Medical	I	Jun-19-2019
6	Teleflex Medical	II	May-29-2019
7	Teleflex Medical	II	Feb-09-2017
8	Teleflex Medical	II	Nov-09-2016
9	Teleflex Medical	II	Jun-09-2016
10	Teleflex Medical	II	Feb-10-2015
11	Teleflex, Inc.	II	Feb-17-2015