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	172	172
Material Deformation	92	92
Break	86	86
Material Frayed	75	75
Difficult to Remove	75	75
Product Quality Problem	68	68
Deformation Due to Compressive Stress	66	66
Fluid/Blood Leak	60	60
Unraveled Material	44	44
Crack	39	39
Physical Resistance/Sticking	38	38
Material Twisted/Bent	32	32
Obstruction of Flow	29	29
Leak/Splash	27	27
Material Separation	21	21
Component Incompatible	20	20
Migration or Expulsion of Device	20	20
Detachment of Device or Device Component	18	18
Migration	17	17
Defective Component	17	17
Adverse Event Without Identified Device or Use Problem	16	16
Material Integrity Problem	15	15
Disconnection	12	12
Infusion or Flow Problem	12	12
Insufficient Flow or Under Infusion	9	9
Failure to Infuse	9	9
Contamination /Decontamination Problem	9	9
Device Markings/Labelling 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
Device Handling Problem	6	6
Material Split, Cut or Torn	5	5
Insufficient Information	5	5
Air/Gas in Device	5	5
Fitting Problem	4	4
Material Fragmentation	4	4
Loose or Intermittent Connection	4	4
Failure to Advance	4	4
Unintended Ejection	3	3
Separation Problem	3	3
Suction Failure	3	3
Mechanical Problem	3	3
Suction Problem	3	3
Malposition of Device	3	3
Mechanics Altered	2	2
Device Slipped	2	2
Improper or Incorrect Procedure or Method	2	2
Device Dislodged or Dislocated	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	580	580
No Consequences Or Impact To Patient	180	180
Insufficient Information	88	88
No Patient Involvement	29	29
No Known Impact Or Consequence To Patient	24	24
No Information	20	20
Hemorrhage/Bleeding	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
Death	3	3
Device Embedded In Tissue or Plaque	3	3
Failure of Implant	3	3
Cardiac Arrest	3	3
Unspecified Infection	2	2
Exsanguination	2	2
Decreased Respiratory Rate	2	2
Low Oxygen Saturation	2	2
Loss of consciousness	2	2
Headache	2	2
Skin Tears	2	2
Erythema	2	2
Pain	2	2
Bradycardia	2	2
Thrombus	1	1
Hemothorax	1	1
Bacterial Infection	1	1
Hypoxia	1	1
Perforation of Vessels	1	1
Anaphylactic Shock	1	1
Asystole	1	1
Pneumonia	1	1
Laceration(s)	1	1
Alteration in Body Temperature	1	1
Thrombosis/Thrombus	1	1
Neck Pain	1	1
Burning Sensation	1	1
Rash	1	1
Fever	1	1
Peritonitis	1	1
Overdose	1	1
Abrasion	1	1