TPLC - Total Product Life Cycle

show TPLC since

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	326	326
Gas/Air Leak	276	276
Leak/Splash	58	58
Material Split, Cut or Torn	58	58
Defective Component	29	29
Break	26	26
Inflation Problem	17	17
Fluid/Blood Leak	14	14
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	8	8
Installation-Related Problem	5	5
Obstruction of Flow	5	5
Material Puncture/Hole	5	5
Crack	5	5
Mechanical Problem	5	5
Contamination /Decontamination Problem	4	4
Material Fragmentation	4	4
Material Rupture	4	4
Nonstandard Device	4	4
Manufacturing, Packaging or Shipping Problem	3	3
Component Missing	3	3
Sharp Edges	3	3
Material Deformation	3	3
Fitting Problem	3	3
Human-Device Interface Problem	3	3
Positioning Failure	2	2
Material Discolored	2	2
Device Markings/Labelling Problem	2	2
Connection Problem	2	2
Disconnection	2	2
Patient-Device Incompatibility	1	1
Deflation Problem	1	1
Device Misassembled During Manufacturing /Shipping	1	1
Complete Blockage	1	1
Peeled/Delaminated	1	1
Insufficient Flow or Under Infusion	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Partial Blockage	1	1
Product Quality Problem	1	1
Physical Resistance/Sticking	1	1
Tear, Rip or Hole in Device Packaging	1	1
Ambient Noise Problem	1	1
Device-Device Incompatibility	1	1
No Apparent Adverse Event	1	1
Missing Information	1	1
Fracture	1	1
Failure to Deflate	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	665	665
Unintended Extubation	83	83
Insufficient Information	42	42
No Patient Involvement	40	40
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
Low Blood Pressure/ Hypotension	1	1
Ventilator Dependent	1	1
Decreased Respiratory Rate	1	1
Fistula	1	1
Unintended Radiation Exposure	1	1