TPLC - Total Product Life Cycle

show TPLC since

Device	catheter, hemodialysis, implanted
Regulation Description	Blood access device and accessories.
Product Code	MSD
Regulation Number	876.5540
Device Class	2

Premarket Reviews
Manufacturer	Decision
BARD PERIPHERAL VASCULAR, INC.
	SUBSTANTIALLY EQUIVALENT - KIT	1
C B BARD, INC.
	SUBSTANTIALLY EQUIVALENT - KIT	1
C.R. BARD, INC.
	SUBSTANTIALLY EQUIVALENT - KIT	1
HAOLANG MEDICAL USA CORPORATION
	SUBSTANTIALLY EQUIVALENT - KIT	1
MEDICAL COMPONENTS INC (MEDCOMP)
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fracture	561	561
Break	551	553
Deformation Due to Compressive Stress	444	444
Fluid/Blood Leak	421	421
Material Puncture/Hole	254	256
Material Deformation	237	237
Crack	210	210
Restricted Flow rate	182	182
Adverse Event Without Identified Device or Use Problem	179	183
Material Separation	170	170
Material Opacification	163	163
Stretched	151	151
Detachment of Device or Device Component	144	144
Expulsion	136	136
Material Discolored	134	134
Insufficient Flow or Under Infusion	131	131
Material Protrusion/Extrusion	128	128
Loosening of Implant Not Related to Bone-Ingrowth	127	127
Obstruction of Flow	126	128
Air/Gas in Device	121	121
Leak/Splash	120	120
Suction Problem	116	116
Difficult to Remove	115	116
Material Integrity Problem	94	94
Defective Component	88	90
Failure to Advance	81	81
Migration	75	79
Physical Resistance/Sticking	57	57
Product Quality Problem	52	52
Difficult to Flush	49	49
Collapse	45	45
Material Split, Cut or Torn	42	42
Packaging Problem	42	42
Material Twisted/Bent	41	41
Loss of or Failure to Bond	39	39
Degraded	35	35
Unraveled Material	35	35
Insufficient Device Problem Information	34	36
Difficult to Insert	34	34
Difficult or Delayed Separation	31	31
Improper or Incorrect Procedure or Method	30	30
Material Fragmentation	29	29
Separation Failure	28	28
Disconnection	25	25
Device Markings/Labelling Problem	25	25
Nonstandard Device	23	23
Component Missing	23	25
Gas/Air Leak	22	22
Connection Problem	22	22
Melted	21	21

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3326	3330
Insufficient Information	333	345
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	137	140
Hemorrhage/Blood Loss/Bleeding	126	126
Unspecified Infection	84	86
Thrombosis/Thrombus	67	68
Bacterial Infection	39	42
Air Embolism	36	36
Foreign Body In Patient	27	27
Unintended Radiation Exposure	26	27
Cardiac Arrest	20	20
Fever	20	20
Failure of Implant	17	17
Sepsis	17	17
Swelling/ Edema	16	17
Pain	15	15
Low Blood Pressure/ Hypotension	15	16
Hematoma	12	12
Bacteremia	10	12
Obstruction/Occlusion	8	8
Perforation of Vessels	8	8
Exsanguination	8	8
Extravasation	8	8
Cardiac Tamponade	7	7
Drug Resistant Bacterial Infection	7	9
Hyperkalemia	7	7
Chest Pain	7	7
Discomfort	7	7
Device Embedded In Tissue or Plaque	7	7
Embolism/Embolus	6	6
Dyspnea	6	6
Purulent Discharge	6	6
No Consequences Or Impact To Patient	5	5
Hypoxia	5	6
Chills	5	5
Skin Erosion	5	5
Hemothorax	5	5
Loss of consciousness	5	5
Stenosis	5	5
Erythema	4	5
Infiltration into Tissue	4	4
Peritonitis	4	4
Pneumothorax	4	4
Unspecified Tissue Injury	3	3
Low Oxygen Saturation	3	3
Septic Shock	3	3
Dizziness	3	3
Stroke/CVA	3	3
Respiratory Failure	3	3
Pulmonary Embolism	3	3