TPLC - Total Product Life Cycle

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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
	SUBSTANTIALLY EQUIVALENT - KIT	1
C.R BARD, INC.
	SUBSTANTIALLY EQUIVALENT - KIT	3
HAOLANG MEDICAL USA CORPORATION
	SUBSTANTIALLY EQUIVALENT - KIT	1
MEDICAL COMPONENTS INC (MEDCOMP)
	SUBSTANTIALLY EQUIVALENT	1
MEDICAL COMPONENTS INC. (DBA MEDCOMP)
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	594	596
Fracture	524	524
Fluid/Blood Leak	397	397
Deformation Due to Compressive Stress	324	324
Material Puncture/Hole	293	295
Crack	210	210
Material Deformation	180	183
Restricted Flow rate	170	170
Detachment of Device or Device Component	169	169
Material Opacification	164	164
Material Separation	158	158
Adverse Event Without Identified Device or Use Problem	151	155
Stretched	143	143
Obstruction of Flow	134	136
Insufficient Flow or Under Infusion	129	129
Leak/Splash	129	130
Material Integrity Problem	113	113
Difficult to Remove	110	111
Air/Gas in Device	101	101
Suction Problem	97	97
Defective Component	93	95
Material Protrusion/Extrusion	91	91
Expulsion	87	87
Loosening of Implant Not Related to Bone-Ingrowth	81	81
Migration	75	79
Material Discolored	69	69
Failure to Advance	60	60
Product Quality Problem	55	55
Collapse	50	50
Difficult to Flush	48	48
Physical Resistance/Sticking	46	46
Material Twisted/Bent	45	45
Packaging Problem	40	40
Material Split, Cut or Torn	40	40
Loss of or Failure to Bond	37	37
Insufficient Information	36	38
Material Fragmentation	35	35
Unraveled Material	31	31
Difficult to Insert	31	31
Difficult or Delayed Separation	30	30
Improper or Incorrect Procedure or Method	30	30
Degraded	28	28
Infusion or Flow Problem	27	27
Component Missing	27	29
Device Markings/Labelling Problem	26	26
Disconnection	26	26
Gas/Air Leak	24	24
Migration or Expulsion of Device	23	23
Melted	23	23
Contamination /Decontamination Problem	21	21

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2907	2911
Insufficient Information	328	340
No Consequences Or Impact To Patient	209	209
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	110	113
Hemorrhage/Bleeding	107	107
Unspecified Infection	77	79
Thrombosis/Thrombus	60	61
No Known Impact Or Consequence To Patient	51	51
Bacterial Infection	37	40
Air Embolism	35	35
Foreign Body In Patient	29	29
Unintended Radiation Exposure	29	30
Cardiac Arrest	19	19
Fever	19	19
Sepsis	17	17
No Patient Involvement	16	16
Device Embedded In Tissue or Plaque	16	16
Swelling/ Edema	15	16
Low Blood Pressure/ Hypotension	15	16
Failure of Implant	13	13
Hematoma	12	12
Pain	11	11
No Information	10	10
Exsanguination	9	9
Perforation of Vessels	9	9
Blood Loss	9	9
Injury	8	8
Chest Pain	7	7
Drug Resistant Bacterial Infection	7	9
Dyspnea	6	6
Extravasation	6	6
Embolism/Embolus	6	6
Cardiac Tamponade	6	6
Purulent Discharge	6	6
Hypoxia	5	6
Stenosis	5	5
Loss of consciousness	5	5
Shock	5	5
Obstruction/Occlusion	5	5
Discomfort	4	4
Erythema	4	5
Infiltration into Tissue	4	4
Chills	4	4
Skin Erosion	4	4
Peritonitis	4	4
Hemothorax	4	4
Death	4	4
No Code Available	4	4
Pneumothorax	4	4
Low Oxygen Saturation	3	3

Recalls
Manufacturer		Recall Class	Date Posted
1	Angiodynamics, Inc.	II	May-03-2024
2	Bard Peripheral Vascular Inc	II	Jun-03-2020
3	Covidien LP	II	Apr-24-2024
4	Covidien LP	II	Sep-25-2023
5	Covidien Llc	I	Jul-07-2022
6	Covidien, LP	II	Aug-27-2021
7	MARVAO MEDICAL DEVICES LTD.	II	Jun-01-2021
8	Medical Components, Inc dba MedComp	II	Sep-06-2020
9	Mozarc Medical US LLC	II	May-30-2025