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TPLC
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Device
catheter, umbilical artery
Product Code
FOS
Regulation Number
880.5200
Device Class
2
Premarket Reviews
Manufacturer
Decision
COVIDIEN LP, FORMERLY REGISTERED AS KENDALL
SUBSTANTIALLY EQUIVALENT
1
FOOTPRINT MEDICAL
SUBSTANTIALLY EQUIVALENT
2
FOOTPRINT MEDICAL INC.
SUBSTANTIALLY EQUIVALENT
1
HAOLANG MEDICAL USA CORPORATION
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
69
69
2015
81
81
2016
115
115
2017
139
139
2018
84
84
2019
64
64
2020
43
43
2021
49
49
2022
38
38
2023
20
20
2024
8
8
Device Problems
MDRs with this Device Problem
Events in those MDRs
Leak/Splash
219
219
Fluid/Blood Leak
195
195
Break
129
129
Crack
91
91
Hole In Material
27
27
Material Fragmentation
17
17
Fracture
14
14
Material Puncture/Hole
13
13
Air Leak
10
10
Detachment of Device or Device Component
10
10
Malposition of Device
8
8
Material Split, Cut or Torn
8
8
Defective Device
7
7
Device Operates Differently Than Expected
7
7
Adverse Event Without Identified Device or Use Problem
7
7
Positioning Problem
7
7
Complete Blockage
7
7
Detachment Of Device Component
7
7
Backflow
7
7
Use of Device Problem
7
7
Material Separation
6
6
Difficult to Remove
6
6
Migration
6
6
Infusion or Flow Problem
6
6
Connection Problem
6
6
Obstruction of Flow
6
6
Split
5
5
Device Markings/Labelling Problem
5
5
Improper Flow or Infusion
5
5
Material Integrity Problem
5
5
Entrapment of Device
5
5
Bent
5
5
Disconnection
4
4
Improper or Incorrect Procedure or Method
4
4
Migration or Expulsion of Device
4
4
Appropriate Term/Code Not Available
4
4
Patient Device Interaction Problem
4
4
Insufficient Information
3
3
Material Perforation
3
3
Air/Gas in Device
3
3
Structural Problem
2
2
Device Displays Incorrect Message
2
2
Torn Material
2
2
Material Deformation
2
2
Device Dislodged or Dislocated
2
2
Filtration Problem
2
2
Moisture Damage
2
2
Occlusion Within Device
2
2
Difficult to Insert
2
2
Kinked
2
2
Reflux within Device
2
2
Material Rupture
2
2
Incorrect, Inadequate or Imprecise Result or Readings
1
1
Material Too Rigid or Stiff
1
1
Fitting Problem
1
1
Stretched
1
1
Product Quality Problem
1
1
Difficult To Position
1
1
Unintended Ejection
1
1
Difficult to Flush
1
1
Flushing Problem
1
1
Burst Container or Vessel
1
1
Component Falling
1
1
Positioning Failure
1
1
Gas/Air Leak
1
1
Unintended Movement
1
1
Output Problem
1
1
Folded
1
1
Defective Component
1
1
Component Missing
1
1
Device Contamination with Body Fluid
1
1
Separation Failure
1
1
Cut In Material
1
1
Incorrect Or Inadequate Test Results
1
1
Separation Problem
1
1
Inaccurate Information
1
1
Unclear Information
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
274
274
No Consequences Or Impact To Patient
123
123
No Clinical Signs, Symptoms or Conditions
62
62
No Information
60
60
Hemorrhage/Bleeding
26
26
Foreign Body In Patient
25
25
Blood Loss
25
25
Device Embedded In Tissue or Plaque
23
23
Insufficient Information
21
21
No Code Available
18
18
Death
12
12
No Patient Involvement
11
11
Pericardial Effusion
6
6
Air Embolism
6
6
Extravasation
5
5
Abdominal Distention
4
4
Fluid Discharge
3
3
Hypoglycemia
3
3
Low Blood Pressure/ Hypotension
3
3
Ischemia
3
3
Sepsis
3
3
Pleural Effusion
2
2
Shock
2
2
Perforation of Vessels
2
2
Cardiac Tamponade
2
2
Liver Contusion
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Unspecified Kidney or Urinary Problem
1
1
Angioedema
1
1
Drug Resistant Bacterial Infection
1
1
Swelling/ Edema
1
1
Patient Problem/Medical Problem
1
1
Test Result
1
1
Liver Damage/Dysfunction
1
1
Liver Laceration(s)
1
1
Internal Organ Perforation
1
1
Pain
1
1
Failure of Implant
1
1
Infiltration into Tissue
1
1
Foreign Body Reaction
1
1
Hematoma
1
1
Exsanguination
1
1
Anemia
1
1
Bacterial Infection
1
1
Coagulation Disorder
1
1
Cardiogenic Shock
1
1
Distress
1
1
Discomfort
1
1
Complaint, Ill-Defined
1
1
Injury
1
1
Extubate
1
1
Irritability
1
1
Low Oxygen Saturation
1
1
Skin Tears
1
1
Lethargy
1
1
Missed Dose
1
1
Vomiting
1
1
Tachycardia
1
1
Renal Failure
1
1
Septic Shock
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Cardinal Health 200, LLC
I
Aug-13-2021
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