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TPLC
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Device
heparin, vascular access flush
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
MDR Year
MDR Reports
MDR Events
2018
19
19
2019
19
19
2020
2
2
2021
10
10
2022
14
14
2023
5
5
Device Problems
MDRs with this Device Problem
Events in those MDRs
Device Markings/Labelling Problem
22
22
Manufacturing, Packaging or Shipping Problem
8
8
Nonstandard Device
6
6
Adverse Event Without Identified Device or Use Problem
4
4
Microbial Contamination of Device
4
4
Patient-Device Incompatibility
3
3
Packaging Problem
3
3
Device Contamination with Chemical or Other Material
3
3
Leak/Splash
3
3
Missing Information
2
2
Insufficient Information
2
2
Volume Accuracy Problem
2
2
Break
2
2
Crack
1
1
Disconnection
1
1
Fluid/Blood Leak
1
1
Hole In Material
1
1
Device Damaged Prior to Use
1
1
Defective Component
1
1
Delivered as Unsterile Product
1
1
Shipping Damage or Problem
1
1
Protective Measures Problem
1
1
Contamination /Decontamination Problem
1
1
Failure to Deliver
1
1
Appropriate Term/Code Not Available
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
17
17
No Clinical Signs, Symptoms or Conditions
15
15
Insufficient Information
10
10
No Patient Involvement
6
6
Nausea
4
4
Bacterial Infection
3
3
Unspecified Infection
3
3
Death
2
2
Diarrhea
2
2
No Consequences Or Impact To Patient
2
2
Respiratory Distress
2
2
Seizures
2
2
Sepsis
2
2
Septic Shock
2
2
Reaction
2
2
Sweating
2
2
Chemical Exposure
2
2
Alteration In Body Temperature
1
1
Abdominal Pain
1
1
No Information
1
1
Constipation
1
1
Swelling
1
1
Thrombosis
1
1
Vomiting
1
1
Complaint, Ill-Defined
1
1
Malaise
1
1
Pain
1
1
Fever
1
1
Hemorrhage/Bleeding
1
1
Inflammation
1
1
Cardiac Arrest
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Mckesson Medical-Surgical Inc. Corporate Office
II
Aug-26-2022
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