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
TERUMO MEDICAL PRODUCTS (HANGZHOU) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	189	189
Material Deformation	127	128
Material Frayed	69	74
Break	58	58
Adverse Event Without Identified Device or Use Problem	58	58
Material Separation	40	40
Difficult or Delayed Separation	38	38
Activation Problem	35	35
Defective Component	24	24
Failure to Infuse	20	20
Material Twisted/Bent	15	15
Improper or Incorrect Procedure or Method	13	13
Material Split, Cut or Torn	11	11
Difficult to Remove	10	10
Detachment of Device or Device Component	9	9
Physical Resistance/Sticking	9	9
Contamination /Decontamination Problem	8	8
Obstruction of Flow	8	9
Product Quality Problem	8	8
Crack	7	9
Difficult to Insert	6	6
Unraveled Material	5	5
Failure to Advance	5	5
Entrapment of Device	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
Suction Problem	2	2
Stretched	2	2
Positioning Failure	2	2
Component Incompatible	2	2
Infusion or Flow Problem	2	2
Misassembled	2	2
Tear, Rip or Hole in Device Packaging	2	2
Material Too Soft/Flexible	1	1
Flushing Problem	1	2
Coagulation in Device or Device Ingredient	1	1
Appropriate Term/Code Not Available	1	1
Device Dislodged or Dislocated	1	1
Fracture	1	1
Device Contamination with Chemical or Other Material	1	1
Deformation Due to Compressive Stress	1	1
Loss of or Failure to Bond	1	1
Dull, Blunt	1	2
Misconnection	1	1
Device Damaged by Another Device	1	1
Blocked Connection	1	2
Component Missing	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	534	540
Insufficient Information	61	63
Foreign Body In Patient	46	46
Swelling/ Edema	29	29
Erythema	23	23
Pain	23	23
Thrombosis/Thrombus	21	21
No Consequences Or Impact To Patient	12	12
Extravasation	12	12
Needle Stick/Puncture	10	11
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
Discomfort	4	4
Unspecified Infection	3	3
Arrhythmia	3	3
Inflammation	3	3
Perforation	3	3
Skin Tears	2	2
Ulcer	2	2
Phlebitis	2	2
Unspecified Tissue Injury	2	3
Anxiety	2	2
Foreign Body Embolism	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
Rash	1	1
Confusion/ Disorientation	1	1
Low Cardiac Output	1	1
Endocarditis	1	1
Obstruction/Occlusion	1	1
Sepsis	1	1
Emotional Changes	1	1
Fibrosis	1	1
Subcutaneous Nodule	1	1
Low Blood Pressure/ Hypotension	1	1
Low Oxygen Saturation	1	1
Ischemia Stroke	1	1
Bruise/Contusion	1	1
Air Embolism	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	ARROW INTERNATIONAL Inc.	II	Oct-19-2022