TPLC - Total Product Life Cycle

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Device	heparin, vascular access flush
Regulation Description	Intravascular catheter.
Definition	Enhance the performance of intravascular catheters, to maintain patency of the vascular catheter when it is not in use.
Product Code	NZW
Regulation Number	880.5200
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Device Markings/Labelling Problem	13	18
Infusion or Flow Problem	7	7
Manufacturing, Packaging or Shipping Problem	5	6
Adverse Event Without Identified Device or Use Problem	4	4
Filling Problem	3	3
Lack of Effect	3	3
Packaging Problem	3	4
Missing Information	3	3
Leak/Splash	2	2
Break	2	2
Off-Label Use	2	2
Volume Accuracy Problem	2	2
Device Contamination with Chemical or Other Material	2	2
Disconnection	1	1
Short Fill	1	1
Insufficient Information	1	1
Failure to Deliver	1	1
Shipping Damage or Problem	1	1
Labelling, Instructions for Use or Training Problem	1	1
Material Separation	1	1
Protective Measures Problem	1	2
Flushing Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	34	35
Insufficient Information	11	16
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
No Known Impact Or Consequence To Patient	2	2
No Patient Involvement	2	2
Unspecified Infection	1	1
Hypersensitivity/Allergic reaction	1	1
Nausea	1	1
Dizziness	1	1
Taste Disorder	1	1
No Consequences Or Impact To Patient	1	1
Low Blood Pressure/ Hypotension	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Mckesson Medical-Surgical Inc. Corporate Office	II	Aug-26-2022