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TPLC
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Device
catheter and tip, suction
Regulation Description
Vacuum-powered body fluid suction apparatus.
Product Code
JOL
Regulation Number
880.6740
Device Class
2
MDR Year
MDR Reports
MDR Events
2020
187
187
2021
283
283
2022
221
221
2023
197
197
2024
277
277
2025
29
29
Device Problems
MDRs with this Device Problem
Events in those MDRs
Obstruction of Flow
518
518
Leak/Splash
145
145
Suction Problem
87
87
Break
53
53
Material Separation
50
50
Material Integrity Problem
44
44
Adverse Event Without Identified Device or Use Problem
42
42
Unraveled Material
35
35
Device Contaminated During Manufacture or Shipping
31
31
Detachment of Device or Device Component
27
27
Activation Problem
19
19
Use of Device Problem
16
16
Material Deformation
14
14
Difficult to Remove
12
12
No Flow
10
10
Suction Failure
8
8
Contamination /Decontamination Problem
8
8
Fluid/Blood Leak
8
8
Material Twisted/Bent
7
7
Entrapment of Device
7
7
Insufficient Information
7
7
Material Frayed
6
6
Gas/Air Leak
5
5
Material Puncture/Hole
5
5
Malposition of Device
5
5
Improper or Incorrect Procedure or Method
4
4
Component Missing
4
4
Patient Device Interaction Problem
4
4
Delivered as Unsterile Product
4
4
Deformation Due to Compressive Stress
4
4
Material Split, Cut or Torn
4
4
Crack
4
4
Fitting Problem
3
3
Manufacturing, Packaging or Shipping Problem
3
3
Partial Blockage
3
3
No Apparent Adverse Event
3
3
Physical Resistance/Sticking
3
3
Connection Problem
3
3
Device Damaged Prior to Use
3
3
Fracture
2
2
Output Problem
2
2
Defective Component
2
2
Sharp Edges
2
2
Backflow
2
2
Difficult to Advance
2
2
Decrease in Suction
2
2
Material Fragmentation
1
1
Difficult to Open or Remove Packaging Material
1
1
Device-Device Incompatibility
1
1
Material Rupture
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
888
888
No Consequences Or Impact To Patient
108
108
Insufficient Information
58
58
Pneumothorax
32
32
Foreign Body In Patient
31
31
No Patient Involvement
16
16
No Code Available
11
11
Unspecified Infection
9
9
Hemorrhage/Bleeding
8
8
Pain
6
6
Failure to Anastomose
6
6
Seroma
6
6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
6
6
Internal Organ Perforation
6
6
Air Embolism
5
5
Swelling
5
5
Not Applicable
5
5
Inflammation
5
5
Reaction
4
4
Hematoma
4
4
Cardiac Tamponade
4
4
Swelling/ Edema
3
3
Pleural Effusion
3
3
Low Oxygen Saturation
3
3
No Known Impact Or Consequence To Patient
3
3
Necrosis
3
3
Laceration(s)
3
3
Pulmonary Emphysema
3
3
Cardiac Perforation
3
3
Unspecified Tissue Injury
2
2
Airway Obstruction
2
2
Loss of consciousness
2
2
Pneumonia
2
2
Bradycardia
2
2
Impaired Healing
2
2
Aspiration/Inhalation
2
2
Device Embedded In Tissue or Plaque
2
2
Abdominal Pain
2
2
Needle Stick/Puncture
2
2
No Information
2
2
Respiratory Distress
2
2
Fistula
2
2
Skin Tears
1
1
Perforation of Vessels
1
1
Increased Respiratory Rate
1
1
Adult Respiratory Distress Syndrome
1
1
Respiratory Failure
1
1
Vascular Dissection
1
1
Pseudoaneurysm
1
1
Chest Pain
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Cardinal Health 200, LLC
I
Feb-16-2024
2
MEDLINE INDUSTRIES, LP - Northfield
I
Feb-25-2024
3
MEDLINE INDUSTRIES, LP - Northfield
II
Jul-20-2023
4
Merit Medical Systems, Inc.
II
Aug-12-2024
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