TPLC - Total Product Life Cycle

• 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

MDR Year	MDR Reports	MDR Events
2014	82	82
2015	51	51
2016	70	70
2017	86	86
2018	120	120
2019	119	119
2020	179	179
2021	192	192
2022	166	166
2023	204	204
2024	65	65

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Puncture/Hole	169	169
Break	125	125
Difficult to Remove	98	98
Material Deformation	92	92
Fluid/Blood Leak	89	89
Material Frayed	85	85
Crack	78	78
Unraveled Material	68	68
Product Quality Problem	66	66
Deformation Due to Compressive Stress	66	66
Leak/Splash	64	64
Kinked	58	58
Physical Resistance/Sticking	42	42
Material Twisted/Bent	32	32
Physical Resistance	29	29
Obstruction of Flow	29	29
Migration or Expulsion of Device	26	26
Material Separation	26	26
Adverse Event Without Identified Device or Use Problem	23	23
Material Integrity Problem	22	22
Detachment of Device or Device Component	19	19
Infusion or Flow Problem	19	19
Component Incompatible	19	19
Defective Component	17	17
Device Operates Differently Than Expected	17	17
Migration	16	16
Disconnection	13	13
Difficult to Insert	12	12
Loose or Intermittent Connection	11	11
Sticking	10	10
Difficult to Advance	10	10
Device Markings/Labelling Problem	9	9
Gas/Air Leak	9	9
Appropriate Term/Code Not Available	9	9
Device Damaged Prior to Use	9	9
Insufficient Flow or Under Infusion	9	9
Failure to Advance	9	9
Failure to Infuse	9	9
Hole In Material	9	9
Bent	9	9
Fracture	8	8
Device Handling Problem	8	8
Contamination /Decontamination Problem	8	8
Material Split, Cut or Torn	7	7
Device Slipped	7	7
Retraction Problem	6	6
Improper or Incorrect Procedure or Method	6	6
Delivered as Unsterile Product	6	6
Insufficient Information	6	6
Air/Gas in Device	5	5
Split	5	5
Entrapment of Device	5	5
Mechanical Problem	4	4
Material Fragmentation	4	4
Malposition of Device	4	4
Connection Problem	4	4
Mechanics Altered	4	4
Material Distortion	3	3
Device Contamination with Chemical or Other Material	3	3
Device Dislodged or Dislocated	3	3
Suction Failure	3	3
Separation Problem	3	3
Protective Measures Problem	3	3
Occlusion Within Device	3	3
Unintended Ejection	3	3
Contamination	3	3
Collapse	3	3
Component Missing	3	3
Material Rupture	3	3
Stretched	2	2
Device Inoperable	2	2
Suction Problem	2	2
Device Issue	2	2
Tear, Rip or Hole in Device Packaging	2	2
Detachment Of Device Component	2	2
Complete Blockage	2	2
Backflow	2	2
Partial Blockage	2	2
Air Leak	2	2
Unsealed Device Packaging	2	2
Fail-Safe Problem	2	2
Packaging Problem	2	2
Activation, Positioning or Separation Problem	2	2
Aspiration Issue	2	2
Failure to Disconnect	2	2
Separation Failure	1	1
Device Displays Incorrect Message	1	1
Biocompatibility	1	1
Folded	1	1
Patient-Device Incompatibility	1	1
Device Operational Issue	1	1
Device Damaged by Another Device	1	1
Device Packaging Compromised	1	1
Positioning Problem	1	1
Pressure Problem	1	1
Output below Specifications	1	1
No Flow	1	1
Expulsion	1	1
Pumping Problem	1	1
Fail-Safe Did Not Operate	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	531	531
No Consequences Or Impact To Patient	311	311
No Known Impact Or Consequence To Patient	177	177
Insufficient Information	76	76
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	21	21
Foreign Body In Patient	15	15
Air Embolism	10	10
Unintended Radiation Exposure	8	8
Hematoma	7	7
Radiation Exposure, Unintended	6	6
Death	6	6
Device Embedded In Tissue or Plaque	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Swelling/ Edema	4	4
Cardiac Arrest	4	4
Low Blood Pressure/ Hypotension	4	4
Pain	4	4
Perforation	3	3
Failure of Implant	3	3
Unspecified Infection	3	3
Laceration(s)	3	3
Exsanguination	3	3
Headache	3	3
Injury	3	3
Low Oxygen Saturation	3	3
Decreased Respiratory Rate	2	2
Skin Tears	2	2
Peritonitis	2	2
Reaction, Injection Site	2	2
Loss of consciousness	2	2
Bradycardia	2	2
Hemothorax	2	2
Erythema	2	2
Cardiopulmonary Arrest	2	2
Anemia	2	2
Apnea	1	1
Bacterial Infection	1	1
Coagulation Disorder	1	1
Anaphylactic Shock	1	1
Abdominal Pain	1	1
Abrasion	1	1
Fever	1	1
Fistula	1	1
Occlusion	1	1
Overdose	1	1
Cardiac Tamponade	1	1
Ischemia	1	1
Hypovolemic Shock	1	1
Hypoxia	1	1
Pneumonia	1	1
Pneumothorax	1	1
Rash	1	1
Increased Sensitivity	1	1
Skin Irritation	1	1
Thrombus	1	1
Transient Ischemic Attack	1	1
Perforation of Vessels	1	1
Vomiting	1	1
Burning Sensation	1	1
Dizziness	1	1
Neck Pain	1	1
Cardiogenic Shock	1	1
Discomfort	1	1
Reaction	1	1
Test Result	1	1
Alteration in Body Temperature	1	1
Embolism/Embolus	1	1
Thrombosis/Thrombus	1	1
Asystole	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