TPLC - Total Product Life Cycle

show TPLC since

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

Premarket Reviews
Manufacturer	Decision
AMECO MEDICAL INDUSTRIES
	SUBSTANTIALLY EQUIVALENT	1
C.R BARD INC.
	SUBSTANTIALLY EQUIVALENT	1
C.R BARD. INC.
	SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS	1
C.R. BARD, INC.
	SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS	1
COOK INCORPORATED
	SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS	1
COOK, INC.
	SUBSTANTIALLY EQUIVALENT - KIT	1
COVIDIEN
	SUBSTANTIALLY EQUIVALENT - KIT	1
COVIDIEN, LLC
	SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS	1
FOSHAN NANHAI BAI HE MEDICAL TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
GAMBRO RENAL PRODUCTS, INC.
	SUBSTANTIALLY EQUIVALENT	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
Break	130	130
Difficult to Remove	102	102
Material Deformation	101	101
Fluid/Blood Leak	94	94
Material Frayed	90	90
Crack	82	82
Unraveled Material	76	76
Product Quality Problem	73	73
Deformation Due to Compressive Stress	66	66
Leak/Splash	65	65
Kinked	58	58
Physical Resistance/Sticking	44	44
Material Twisted/Bent	37	37
Obstruction of Flow	30	30
Physical Resistance	29	29
Material Separation	28	28
Migration or Expulsion of Device	26	26
Material Integrity Problem	23	23
Adverse Event Without Identified Device or Use Problem	23	23
Component Incompatible	20	20
Detachment of Device or Device Component	20	20
Infusion or Flow Problem	19	19
Defective Component	18	18
Device Operates Differently Than Expected	17	17
Migration	17	17
Disconnection	14	14
Difficult to Insert	12	12
Loose or Intermittent Connection	11	11
Device Damaged Prior to Use	10	10
Difficult to Advance	10	10
Sticking	10	10
Bent	9	9
Device Markings/Labelling Problem	9	9
Failure to Infuse	9	9
Appropriate Term/Code Not Available	9	9
Failure to Advance	9	9
Contamination /Decontamination Problem	9	9
Hole In Material	9	9
Insufficient Flow or Under Infusion	9	9
Gas/Air Leak	9	9
Device Handling Problem	8	8
Fracture	8	8
Device Slipped	7	7
Material Split, Cut or Torn	7	7
Retraction Problem	6	6
Delivered as Unsterile Product	6	6
Insufficient Information	6	6
Improper or Incorrect Procedure or Method	6	6
Material Fragmentation	5	5

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	311	311
No Known Impact Or Consequence To Patient	177	177
Insufficient Information	88	88
No Information	61	61
Blood Loss	41	41
No Patient Involvement	39	39
Needle Stick/Puncture	28	28
No Code Available	25	25
Hemorrhage/Bleeding	23	23
Foreign Body In Patient	17	17
Air Embolism	10	10
Hematoma	9	9
Unintended Radiation Exposure	8	8
Death	6	6
Radiation Exposure, Unintended	6	6
Device Embedded In Tissue or Plaque	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Pain	4	4
Swelling/ Edema	4	4
Low Blood Pressure/ Hypotension	4	4
Cardiac Arrest	4	4
Laceration(s)	3	3
Injury	3	3
Headache	3	3
Perforation	3	3
Exsanguination	3	3
Low Oxygen Saturation	3	3
Failure of Implant	3	3
Unspecified Infection	3	3
Anemia	2	2
Loss of consciousness	2	2
Reaction, Injection Site	2	2
Peritonitis	2	2
Skin Tears	2	2
Hemothorax	2	2
Decreased Respiratory Rate	2	2
Erythema	2	2
Bradycardia	2	2
Cardiopulmonary Arrest	2	2
Bacterial Infection	1	1
Hypoxia	1	1
Perforation of Vessels	1	1
Anaphylactic Shock	1	1
Asystole	1	1
Reaction	1	1
Thrombus	1	1
Fistula	1	1
Pneumonia	1	1
Increased Sensitivity	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Arrow International Inc	II	Apr-10-2018
2	Arrow International Inc	II	Feb-20-2018
3	Arrow International Inc	II	Jun-12-2017
4	Cordis Corporation	II	Aug-18-2015
5	Medical Components, Inc dba MedComp	II	Aug-25-2018
6	Medtronic Minimally Invasive Therapies Group	II	Mar-14-2018