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	195	195
Material Deformation	127	128
Break	68	68
Adverse Event Without Identified Device or Use Problem	64	64
Material Frayed	63	68
Material Separation	42	42
Difficult or Delayed Separation	34	34
Activation Problem	33	33
Defective Component	33	33
Failure to Infuse	20	20
Material Twisted/Bent	14	14
Material Split, Cut or Torn	13	13
Detachment of Device or Device Component	11	11
Improper or Incorrect Procedure or Method	11	11
Physical Resistance/Sticking	10	10
Obstruction of Flow	8	9
Difficult to Remove	8	8
Crack	7	9
Contamination /Decontamination Problem	6	6
Difficult to Insert	6	6
Failure to Advance	6	6
Entrapment of Device	6	6
Unraveled Material	5	5
Patient-Device Incompatibility	4	4
Device Markings/Labelling Problem	4	4
Premature Separation	4	4
Difficult to Advance	3	3
Unsealed Device Packaging	3	3
Leak/Splash	3	3
Component Incompatible	2	2
Suction Problem	2	2
Material Integrity Problem	2	2
Stretched	2	2
Coagulation in Device or Device Ingredient	2	2
Positioning Failure	2	2
Device Dislodged or Dislocated	2	2
Component Missing	2	2
Infusion or Flow Problem	2	2
Fracture	2	2
Product Quality Problem	2	2
Tear, Rip or Hole in Device Packaging	2	2
Material Too Soft/Flexible	1	1
Flushing Problem	1	2
Difficult to Open or Close	1	1
Appropriate Term/Code Not Available	1	1
Deformation Due to Compressive Stress	1	1
Loss of or Failure to Bond	1	1
Dull, Blunt	1	2
Material Protrusion/Extrusion	1	1
Device Contamination with Chemical or Other Material	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	480	486
No Consequences Or Impact To Patient	80	80
Insufficient Information	59	61
Foreign Body In Patient	45	45
Swelling/ Edema	28	28
Erythema	23	23
Pain	21	21
Thrombosis/Thrombus	20	20
Needle Stick/Puncture	10	11
Extravasation	10	10
Thrombus	7	7
Device Embedded In Tissue or Plaque	5	5
Hemorrhage/Bleeding	5	5
Skin Inflammation/ Irritation	5	5
Hematoma	5	5
Laceration(s)	5	6
Infiltration into Tissue	4	4
No Known Impact Or Consequence To Patient	4	4
No Patient Involvement	4	4
Unspecified Infection	3	3
Arrhythmia	3	3
Inflammation	3	3
Perforation	3	3
Discomfort	3	3
Skin Tears	2	2
Ulcer	2	2
Phlebitis	2	2
Unspecified Tissue Injury	2	3
Foreign Body Embolism	2	2
Thrombosis	2	2
Anaphylactoid	2	2
Hypersensitivity/Allergic reaction	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Dyspnea	1	1
Numbness	1	1
Coma	1	1
Abscess	1	1
Exposure to Body Fluids	1	1
Shock	1	1
Anxiety	1	1
Rash	1	1
Confusion/ Disorientation	1	1
Endocarditis	1	1
Low Cardiac Output	1	1
Obstruction/Occlusion	1	1
Sepsis	1	1
Emotional Changes	1	1
Subcutaneous Nodule	1	1
Low Blood Pressure/ Hypotension	1	1
Low Oxygen Saturation	1	1