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	287	287
Gas/Air Leak	260	260
Leak/Splash	57	57
Material Split, Cut or Torn	55	55
Defective Component	30	30
Break	26	26
Inflation Problem	17	17
Fluid/Blood Leak	13	13
Insufficient Information	11	11
Material Separation	10	10
Appropriate Term/Code Not Available	8	8
Detachment of Device or Device Component	8	8
Material Integrity Problem	7	7
Crack	5	5
Obstruction of Flow	5	5
Human-Device Interface Problem	4	4
Mechanical Problem	4	4
Nonstandard Device	4	4
Installation-Related Problem	4	4
Material Rupture	4	4
Contamination /Decontamination Problem	4	4
Material Fragmentation	4	4
Fitting Problem	3	3
Material Deformation	3	3
Manufacturing, Packaging or Shipping Problem	3	3
Sharp Edges	3	3
Component Missing	3	3
Material Discolored	2	2
Positioning Failure	2	2
Material Puncture/Hole	2	2
Device Markings/Labelling Problem	2	2
Disconnection	2	2
Insufficient Flow or Under Infusion	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Device Misassembled During Manufacturing /Shipping	1	1
Deflation Problem	1	1
Patient-Device Incompatibility	1	1
Partial Blockage	1	1
Product Quality Problem	1	1
Tear, Rip or Hole in Device Packaging	1	1
Ambient Noise Problem	1	1
Complete Blockage	1	1
No Apparent Adverse Event	1	1
Missing Information	1	1
Fracture	1	1
Peeled/Delaminated	1	1
Physical Resistance/Sticking	1	1
Connection Problem	1	1
Device-Device Incompatibility	1	1
Failure to Deflate	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	625	625
Unintended Extubation	73	73
No Patient Involvement	40	40
Insufficient Information	25	25
No Consequences Or Impact To Patient	18	18
Low Oxygen Saturation	17	17
Unspecified Tissue Injury	10	10
Extubate	9	9
Hemorrhage/Bleeding	4	4
Tissue Breakdown	4	4
Hypoventilation	3	3
Adult Respiratory Distress Syndrome	3	3
Injury	3	3
Pain	3	3
Pneumothorax	2	2
No Information	2	2
Foreign Body In Patient	2	2
Laceration(s)	2	2
Arrhythmia	1	1
Perforation of Esophagus	1	1
No Known Impact Or Consequence To Patient	1	1
Dyspnea	1	1
Dysphagia/ Odynophagia	1	1
Therapeutic Response, Decreased	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