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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
HAOLANG MEDICAL USA CORPORATION
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2017
139
139
2018
84
84
2019
64
64
2020
43
43
2021
49
49
2022
38
38
2023
20
20
2024
34
34
Device Problems
MDRs with this Device Problem
Events in those MDRs
Leak/Splash
140
140
Fluid/Blood Leak
111
111
Break
91
91
Crack
47
47
Material Puncture/Hole
13
13
Material Fragmentation
12
12
Connection Problem
11
11
Fracture
10
10
Hole In Material
9
9
Detachment of Device or Device Component
9
9
Material Split, Cut or Torn
8
8
Adverse Event Without Identified Device or Use Problem
7
7
Obstruction of Flow
7
7
Migration
7
7
Complete Blockage
6
6
Positioning Problem
6
6
Use of Device Problem
6
6
Infusion or Flow Problem
5
5
Material Separation
5
5
Malposition of Device
4
4
Device Markings/Labelling Problem
4
4
Appropriate Term/Code Not Available
4
4
Defective Device
4
4
Material Integrity Problem
4
4
Patient Device Interaction Problem
4
4
Backflow
3
3
Difficult to Remove
3
3
Air/Gas in Device
3
3
Material Perforation
2
2
Material Rupture
2
2
Occlusion Within Device
2
2
Gas/Air Leak
2
2
Improper Flow or Infusion
2
2
Air Leak
2
2
Improper or Incorrect Procedure or Method
2
2
Migration or Expulsion of Device
2
2
Disconnection
2
2
Product Quality Problem
1
1
Device Dislodged or Dislocated
1
1
Flushing Problem
1
1
Material Deformation
1
1
Inaccurate Information
1
1
Device Displays Incorrect Message
1
1
Structural Problem
1
1
Detachment Of Device Component
1
1
Positioning Failure
1
1
Material Too Rigid or Stiff
1
1
Unintended Ejection
1
1
Component Missing
1
1
Difficult to Insert
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
112
112
No Consequences Or Impact To Patient
105
105
No Clinical Signs, Symptoms or Conditions
82
82
No Information
39
39
Foreign Body In Patient
26
26
Insufficient Information
24
24
Device Embedded In Tissue or Plaque
16
16
Blood Loss
15
15
Hemorrhage/Bleeding
12
12
No Patient Involvement
8
8
Air Embolism
6
6
Pericardial Effusion
6
6
Death
4
4
No Code Available
4
4
Extravasation
4
4
Abdominal Distention
3
3
Pleural Effusion
3
3
Fluid Discharge
3
3
Hypoglycemia
3
3
Liver Contusion
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Low Blood Pressure/ Hypotension
2
2
Cardiac Tamponade
2
2
Perforation of Vessels
2
2
Angioedema
1
1
Liver Laceration(s)
1
1
Low Oxygen Saturation
1
1
Ascites
1
1
Bacterial Infection
1
1
Irritability
1
1
Skin Tears
1
1
Swelling/ Edema
1
1
Tachycardia
1
1
Renal Failure
1
1
Pain
1
1
Unspecified Kidney or Urinary Problem
1
1
Discomfort
1
1
Cardiogenic Shock
1
1
Septic Shock
1
1
Vomiting
1
1
Intracranial Hemorrhage
1
1
Injury
1
1
Respiratory Acidosis
1
1
Anemia
1
1
Hematoma
1
1
Missed Dose
1
1
Sepsis
1
1
Failure of Implant
1
1
Drug Resistant Bacterial Infection
1
1
Patient Problem/Medical Problem
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Cardinal Health 200, LLC
I
Aug-13-2021
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