TPLC - Total Product Life Cycle

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Device	midline catheter
Regulation Description	Intravascular catheter.
Definition	The catheter is inserted into the peripheral vascular system for infusion of fluids and medications for less than 28 days.
Product Code	PND
Regulation Number	880.5200
Device Class	2

Premarket Reviews
Manufacturer	Decision
ARROW INTERNATIONAL LLC SUBSIDIARY OF TELEFLEX INCORPORATED
	SUBSTANTIALLY EQUIVALENT	1
C. R. BARD, INC.
	SUBSTANTIALLY EQUIVALENT	1
PIPER ACCESS, LLC
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	177	177
Material Deformation	117	117
Break	62	62
Material Frayed	58	58
Adverse Event Without Identified Device or Use Problem	56	56
Material Separation	40	40
Defective Component	29	29
Difficult or Delayed Separation	28	28
Activation Problem	23	23
Failure to Infuse	15	15
Material Split, Cut or Torn	13	13
Material Twisted/Bent	11	11
Detachment of Device or Device Component	8	8
Improper or Incorrect Procedure or Method	8	8
Physical Resistance/Sticking	8	8
Crack	7	7
Obstruction of Flow	7	7
Entrapment of Device	6	6
Difficult to Remove	5	5
Difficult to Insert	5	5
Unraveled Material	5	5
Premature Separation	4	4
Patient-Device Incompatibility	4	4
Device Markings/Labelling Problem	3	3
Difficult to Advance	3	3
Unsealed Device Packaging	3	3
Contamination /Decontamination Problem	3	3
Failure to Advance	3	3
Leak/Splash	3	3
Suction Problem	2	2
Material Integrity Problem	2	2
Coagulation in Device or Device Ingredient	2	2
Device Dislodged or Dislocated	2	2
Component Missing	2	2
Infusion or Flow Problem	2	2
Fracture	2	2
Tear, Rip or Hole in Device Packaging	2	2
Difficult to Open or Close	1	1
Component Incompatible	1	1
Material Too Soft/Flexible	1	1
Flushing Problem	1	1
Appropriate Term/Code Not Available	1	1
Deformation Due to Compressive Stress	1	1
Material Protrusion/Extrusion	1	1
Loss of or Failure to Bond	1	1
Dull, Blunt	1	1
Misconnection	1	1
Misassembled	1	1
Blocked Connection	1	1
Use of Device Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	415	415
No Consequences Or Impact To Patient	80	80
Insufficient Information	56	56
Foreign Body In Patient	43	43
Swelling/ Edema	25	25
Erythema	23	23
Pain	17	17
Thrombosis/Thrombus	16	16
Needle Stick/Puncture	10	10
Thrombus	7	7
Extravasation	6	6
Device Embedded In Tissue or Plaque	5	5
Hemorrhage/Bleeding	5	5
Skin Inflammation/ Irritation	5	5
Hematoma	5	5
Laceration(s)	5	5
Infiltration into Tissue	4	4
No Patient Involvement	4	4
No Known Impact Or Consequence To Patient	4	4
Discomfort	3	3
Perforation	3	3
Inflammation	3	3
Unspecified Infection	3	3
Thrombosis	2	2
Foreign Body Embolism	2	2
Unspecified Tissue Injury	2	2
Phlebitis	2	2
Ulcer	2	2
Skin Tears	2	2
Hypersensitivity/Allergic reaction	2	2
Arrhythmia	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Rash	1	1
Exposure to Body Fluids	1	1
Numbness	1	1
Confusion/ Disorientation	1	1
Low Cardiac Output	1	1
Obstruction/Occlusion	1	1
Anaphylactoid	1	1
Coma	1	1
Abscess	1	1
Shock	1	1
Anxiety	1	1
Endocarditis	1	1
Subcutaneous Nodule	1	1
Low Oxygen Saturation	1	1
Ischemia Stroke	1	1
Bruise/Contusion	1	1
Air Embolism	1	1