TPLC - Total Product Life Cycle

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Device	catheter, hemodialysis, non-implanted
Product Code	MPB
Regulation Number	876.5540
Device Class	2

Premarket Reviews
Manufacturer	Decision
COVIDIEN, LLC
	SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS	1
HEALTH LINE INTERNATIONAL CORPORATION
	SUBSTANTIALLY EQUIVALENT - KIT	1
MEDICAL COMPONENTS INC. (DBA MEDCOMP)
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Puncture/Hole	175	175
Material Deformation	100	100
Break	88	88
Material Frayed	76	76
Difficult to Remove	76	76
Product Quality Problem	72	72
Deformation Due to Compressive Stress	66	66
Fluid/Blood Leak	65	65
Unraveled Material	46	46
Material Twisted/Bent	41	41
Physical Resistance/Sticking	40	40
Crack	40	40
Obstruction of Flow	34	34
Leak/Splash	27	27
Material Separation	23	23
Detachment of Device or Device Component	21	21
Migration or Expulsion of Device	21	21
Component Incompatible	20	20
Adverse Event Without Identified Device or Use Problem	18	18
Migration	17	17
Defective Component	17	17
Material Integrity Problem	15	15
Disconnection	13	13
Infusion or Flow Problem	12	12
Insufficient Flow or Under Infusion	10	10
Device Markings/Labelling Problem	9	9
Failure to Infuse	9	9
Contamination /Decontamination Problem	9	9
Difficult to Advance	8	8
Gas/Air Leak	8	8
Difficult to Insert	7	7
Device Damaged Prior to Use	6	6
Material Split, Cut or Torn	6	6
Device Handling Problem	6	6
Insufficient Information	5	5
Air/Gas in Device	5	5
Material Fragmentation	5	5
Failure to Advance	4	4
Loose or Intermittent Connection	4	4
Fitting Problem	4	4
Separation Problem	4	4
Suction Failure	3	3
Output Problem	3	3
Suction Problem	3	3
Unintended Ejection	3	3
Malposition of Device	3	3
Mechanical Problem	3	3
Device Dislodged or Dislocated	2	2
Device Contamination with Chemical or Other Material	2	2
Tear, Rip or Hole in Device Packaging	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	616	616
No Consequences Or Impact To Patient	180	180
Insufficient Information	97	97
No Patient Involvement	29	29
No Known Impact Or Consequence To Patient	24	24
Hemorrhage/Bleeding	21	21
No Information	20	20
Foreign Body In Patient	16	16
Needle Stick/Puncture	14	14
Blood Loss	13	13
Hematoma	9	9
Unintended Radiation Exposure	8	8
No Code Available	8	8
Air Embolism	6	6
Radiation Exposure, Unintended	6	6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Low Blood Pressure/ Hypotension	4	4
Swelling/ Edema	4	4
Unspecified Infection	3	3
Death	3	3
Device Embedded In Tissue or Plaque	3	3
Failure of Implant	3	3
Cardiac Arrest	3	3
Pain	3	3
Exsanguination	2	2
Decreased Respiratory Rate	2	2
Low Oxygen Saturation	2	2
Loss of consciousness	2	2
Fever	2	2
Thrombosis/Thrombus	2	2
Headache	2	2
Erythema	2	2
Skin Tears	2	2
Bradycardia	2	2
Thrombus	1	1
Hemothorax	1	1
Bacterial Infection	1	1
Hypoxia	1	1
Perforation of Vessels	1	1
Asystole	1	1
Pneumonia	1	1
Laceration(s)	1	1
Alteration in Body Temperature	1	1
Discomfort	1	1
Neck Pain	1	1
Chills	1	1
Burning Sensation	1	1
Peritonitis	1	1
Overdose	1	1
Abrasion	1	1