TPLC - Total Product Life Cycle

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Device	catheter, subclavian
Regulation Description	Blood access device and accessories.
Product Code	LFJ
Regulation Number	876.5540
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Twisted/Bent	43	43
Unraveled Material	33	33
Deformation Due to Compressive Stress	27	27
Break	19	19
Material Deformation	15	15
Physical Resistance/Sticking	14	14
Fluid/Blood Leak	10	10
Difficult to Remove	8	8
Material Separation	8	8
Material Puncture/Hole	6	6
Difficult to Insert	6	6
Crack	5	5
Component Incompatible	5	5
Fracture	5	5
Leak/Splash	4	4
Obstruction of Flow	4	4
Defective Component	3	3
Gas/Air Leak	3	3
Material Frayed	2	2
Fitting Problem	2	2
Material Too Soft/Flexible	2	2
Complete Blockage	2	2
Insufficient Information	2	2
Material Integrity Problem	2	2
Failure to Infuse	2	2
Product Quality Problem	2	2
Loose or Intermittent Connection	1	1
Naturally Worn	1	1
Component Misassembled	1	1
Migration	1	1
Tear, Rip or Hole in Device Packaging	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Improper Flow or Infusion	1	1
Material Discolored	1	1
Positioning Failure	1	1
Stretched	1	1
Material Fragmentation	1	1
Material Invagination	1	1
Suction Failure	1	1
Pumping Problem	1	1
Output Problem	1	1
Mechanical Problem	1	1
Material Split, Cut or Torn	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	183	183
Insufficient Information	10	10
Hemorrhage/Bleeding	3	3
Unspecified Infection	2	2
Intraoperative Pain	2	2
Hematoma	2	2
Anemia	2	2
Chest Pain	2	2
No Consequences Or Impact To Patient	2	2
Stacking Breaths	1	1
Arrhythmia	1	1
Stroke/CVA	1	1
Nausea	1	1
Sepsis	1	1
Diaphoresis	1	1
Easy Bruising	1	1
Cardiac Arrest	1	1
Fever	1	1
Foreign Body In Patient	1	1
Myocardial Infarction	1	1
Respiratory Insufficiency	1	1
Loss of consciousness	1	1
Bacterial Infection	1	1
Unintended Radiation Exposure	1	1