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	337	337
Gas/Air Leak	236	236
Leak/Splash	63	64
Material Split, Cut or Torn	59	59
Defective Component	26	26
Break	22	22
Inflation Problem	15	15
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
Contamination /Decontamination Problem	5	5
Material Rupture	4	4
Material Puncture/Hole	4	4
Material Fragmentation	4	4
Human-Device Interface Problem	3	3
Sharp Edges	3	3
Manufacturing, Packaging or Shipping Problem	3	3
Mechanical Problem	3	3
Fitting Problem	3	3
Disconnection	3	3
Positioning Failure	2	2
Material Discolored	2	2
Unintended Movement	2	2
Material Deformation	2	2
Device Markings/Labelling Problem	2	2
Tear, Rip or Hole in Device Packaging	2	2
Connection Problem	2	2
Device Misassembled During Manufacturing /Shipping	1	1
Deflation Problem	1	1
Component Missing	1	1
Defective Device	1	1
Insufficient Flow or Under Infusion	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Patient-Device Incompatibility	1	1
Complete Blockage	1	1
Partial Blockage	1	1
Product Quality Problem	1	1
Ambient Noise Problem	1	1
Peeled/Delaminated	1	1
Physical Resistance/Sticking	1	1
No Apparent Adverse Event	1	1
Missing Information	1	1
Fracture	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	685	686
Unintended Extubation	88	88
Insufficient Information	45	45
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
Pneumothorax	1	1
Arrhythmia	1	1
Perforation of Esophagus	1	1
Dyspnea	1	1
Dysphagia/ Odynophagia	1	1
Sore Throat	1	1
Ventilator Dependent	1	1
Low Blood Pressure/ Hypotension	1	1
Decreased Respiratory Rate	1	1
Fistula	1	1
Unintended Radiation Exposure	1	1
Device Embedded In Tissue or Plaque	1	1