TPLC - Total Product Life Cycle

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Device	catheter, hemodialysis, non-implanted
Regulation Description	Blood access device and accessories.
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
MEDICAL COMPONENTS, INC
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Puncture/Hole	166	166
Material Deformation	107	107
Break	88	88
Difficult to Remove	88	88
Material Frayed	76	76
Fluid/Blood Leak	68	68
Unraveled Material	66	66
Deformation Due to Compressive Stress	63	63
Material Twisted/Bent	62	62
Product Quality Problem	58	58
Crack	38	38
Obstruction of Flow	34	34
Physical Resistance/Sticking	34	34
Leak/Splash	29	29
Adverse Event Without Identified Device or Use Problem	28	28
Detachment of Device or Device Component	23	23
Material Separation	23	23
Component Incompatible	21	21
Defective Component	21	21
Migration	20	20
Migration or Expulsion of Device	18	18
Material Integrity Problem	13	13
Disconnection	12	12
Contamination /Decontamination Problem	11	11
Insufficient Flow or Under Infusion	11	11
Failure to Infuse	10	10
Infusion or Flow Problem	10	10
Difficult to Advance	8	8
Material Fragmentation	8	8
Difficult to Insert	8	8
Device Slipped	7	7
Insufficient Information	7	7
Device Markings/Labelling Problem	7	7
Material Split, Cut or Torn	7	7
Gas/Air Leak	7	7
Air/Gas in Device	6	6
Device Handling Problem	6	6
Device Damaged Prior to Use	5	5
Loose or Intermittent Connection	4	4
Fitting Problem	4	4
Device Dislodged or Dislocated	4	4
Separation Problem	4	4
Suction Problem	3	3
Failure to Advance	3	3
Mechanical Problem	3	3
Output Problem	3	3
Suction Failure	3	3
Entrapment of Device	2	2
Misassembled	2	2
Delivered as Unsterile Product	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	751	751
Insufficient Information	117	117
No Consequences Or Impact To Patient	115	115
Hemorrhage/Bleeding	21	21
Foreign Body In Patient	18	18
Needle Stick/Puncture	15	15
Hematoma	12	12
No Information	10	10
No Patient Involvement	10	10
Blood Loss	9	9
Unintended Radiation Exposure	8	8
Air Embolism	7	7
Unspecified Infection	6	6
Radiation Exposure, Unintended	5	5
Pain	5	5
Swelling/ Edema	4	4
No Code Available	4	4
Cardiac Arrest	4	4
Fever	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Failure of Implant	3	3
Exsanguination	3	3
Low Oxygen Saturation	3	3
Thrombosis/Thrombus	3	3
Skin Tears	2	2
Bradycardia	2	2
Bacterial Infection	2	2
Erythema	2	2
Loss of consciousness	2	2
Chills	2	2
Low Blood Pressure/ Hypotension	2	2
No Known Impact Or Consequence To Patient	2	2
Decreased Respiratory Rate	2	2
Embolism/Embolus	2	2
Distress	2	2
Death	2	2
Arrhythmia	2	2
Headache	1	1
Unspecified Vascular Problem	1	1
Hemothorax	1	1
Thrombus	1	1
Blurred Vision	1	1
Hypoxia	1	1
Hypovolemia	1	1
Stenosis	1	1
Perforation of Vessels	1	1
Asystole	1	1
Pneumonia	1	1
Laceration(s)	1	1
Dyspnea	1	1