TPLC - Total Product Life Cycle

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Device	tube, bronchial (w/wo connector)
Regulation Description	Bronchial tube.
Product Code	BTS
Regulation Number	868.5720
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Use of Device Problem	327	327
Gas/Air Leak	221	221
Leak/Splash	61	62
Material Split, Cut or Torn	55	55
Defective Component	26	26
Break	22	22
Inflation Problem	14	14
Fluid/Blood Leak	13	13
Insufficient Information	11	11
Material Separation	8	8
Material Integrity Problem	8	8
Appropriate Term/Code Not Available	7	7
Crack	7	7
Obstruction of Flow	6	6
Nonstandard Device	5	5
Installation-Related Problem	5	5
Detachment of Device or Device Component	5	5
Material Rupture	4	4
Material Fragmentation	4	4
Contamination /Decontamination Problem	4	4
Material Puncture/Hole	4	4
Manufacturing, Packaging or Shipping Problem	3	3
Sharp Edges	3	3
Mechanical Problem	3	3
Fitting Problem	3	3
Human-Device Interface Problem	3	3
Disconnection	3	3
Positioning Failure	2	2
Material Discolored	2	2
Device Markings/Labelling Problem	2	2
Material Deformation	2	2
Tear, Rip or Hole in Device Packaging	2	2
Connection Problem	2	2
Deflation Problem	1	1
Device Misassembled During Manufacturing /Shipping	1	1
Defective Device	1	1
Component Missing	1	1
Patient-Device Incompatibility	1	1
Insufficient Flow or Under Infusion	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Complete Blockage	1	1
Partial Blockage	1	1
Product Quality Problem	1	1
Peeled/Delaminated	1	1
Ambient Noise Problem	1	1
Physical Resistance/Sticking	1	1
No Apparent Adverse Event	1	1
Missing Information	1	1
Fracture	1	1
Device-Device Incompatibility	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	662	663
Unintended Extubation	80	80
Insufficient Information	42	42
Low Oxygen Saturation	17	17
Unspecified Tissue Injury	10	10
Hemorrhage/Bleeding	4	4
Tissue Breakdown	4	4
Adult Respiratory Distress Syndrome	3	3
Foreign Body In Patient	3	3
Pain	3	3
Hypoventilation	2	2
Laceration(s)	2	2
Arrhythmia	1	1
Pneumothorax	1	1
Perforation of Esophagus	1	1
Dyspnea	1	1
Dysphagia/ Odynophagia	1	1
Sore Throat	1	1
Low Blood Pressure/ Hypotension	1	1
Ventilator Dependent	1	1
Decreased Respiratory Rate	1	1
Fistula	1	1
Device Embedded In Tissue or Plaque	1	1
Unintended Radiation Exposure	1	1