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TPLC
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show TPLC since
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Device
catheter and tip, suction
Product Code
JOL
Regulation Number
880.6740
Device Class
2
MDR Year
MDR Reports
MDR Events
2017
179
179
2018
161
161
2019
442
442
2020
187
187
2021
283
283
2022
136
136
Device Problems
MDRs with this Device Problem
Events in those MDRs
Device Contamination with Chemical or Other Material
299
299
Obstruction of Flow
273
273
Suction Problem
214
214
Leak/Splash
86
86
Break
80
80
Detachment of Device or Device Component
73
73
Material Separation
59
59
Adverse Event Without Identified Device or Use Problem
41
41
Disconnection
32
32
Fluid Leak
31
31
Device Contaminated During Manufacture or Shipping
21
21
Decrease in Suction
18
18
Unraveled Material
16
16
Use of Device Problem
14
14
Detachment Of Device Component
11
11
Activation Problem
11
11
Appropriate Term/Code Not Available
10
10
Material Integrity Problem
10
10
Material Deformation
9
9
Contamination /Decontamination Problem
9
9
Entrapment of Device
9
9
Kinked
8
8
Device Damaged Prior to Use
8
8
Fitting Problem
7
7
Material Frayed
7
7
Difficult to Remove
7
7
Fracture
6
6
Component Missing
6
6
No Flow
6
6
Suction Failure
6
6
Hole In Material
5
5
Crack
5
5
Loose or Intermittent Connection
5
5
Delivered as Unsterile Product
4
4
Material Too Rigid or Stiff
4
4
No Apparent Adverse Event
4
4
Insufficient Information
3
3
Material Split, Cut or Torn
3
3
Physical Resistance/Sticking
3
3
Material Puncture/Hole
3
3
Device Markings/Labelling Problem
3
3
Device Operates Differently Than Expected
3
3
Defective Component
3
3
Gas Leak
3
3
Difficult to Advance
2
2
Material Twisted/Bent
2
2
Output Problem
2
2
Packaging Problem
2
2
Reflux within Device
2
2
Improper or Incorrect Procedure or Method
2
2
Shelf Life Exceeded
2
2
Component Falling
2
2
Contamination
2
2
Complete Blockage
2
2
Backflow
2
2
Partial Blockage
2
2
Sharp Edges
2
2
Separation Problem
2
2
Inaccurate Information
2
2
Air/Gas in Device
1
1
Noise, Audible
1
1
Collapse
1
1
Air Leak
1
1
Material Fragmentation
1
1
Smoking
1
1
Occlusion Within Device
1
1
Overheating of Device
1
1
Unsealed Device Packaging
1
1
Peeled/Delaminated
1
1
Mechanical Problem
1
1
Melted
1
1
Migration or Expulsion of Device
1
1
Poor Quality Image
1
1
Nonstandard Device
1
1
Scratched Material
1
1
Therapeutic or Diagnostic Output Failure
1
1
Torn Material
1
1
Unintended Movement
1
1
Misassembly by Users
1
1
Difficult to Open or Remove Packaging Material
1
1
Device Dislodged or Dislocated
1
1
Infusion or Flow Problem
1
1
Material Perforation
1
1
Failure to Advance
1
1
Defective Device
1
1
Device Or Device Fragments Location Unknown
1
1
Malposition of Device
1
1
Patient-Device Incompatibility
1
1
Blocked Connection
1
1
Device Operational Issue
1
1
Device Packaging Compromised
1
1
Out-Of-Box Failure
1
1
Incomplete or Missing Packaging
1
1
Connection Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
398
398
No Consequences Or Impact To Patient
358
358
No Patient Involvement
338
338
No Known Impact Or Consequence To Patient
128
128
No Code Available
30
30
Foreign Body In Patient
29
29
No Information
23
23
Pneumothorax
23
23
Insufficient Information
20
20
Not Applicable
11
11
Swelling
9
9
Pain
8
8
Hemorrhage/Bleeding
6
6
Unspecified Infection
6
6
Failure to Anastomose
5
5
Death
5
5
Seroma
5
5
Reaction
4
4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
4
4
Inflammation
4
4
Pleural Effusion
4
4
Pneumonia
4
4
Laceration(s)
3
3
Necrosis
3
3
Internal Organ Perforation
3
3
Fistula
3
3
Hematoma
3
3
Bradycardia
3
3
Air Embolism
3
3
Device Embedded In Tissue or Plaque
3
3
Injury
3
3
Impaired Healing
2
2
Obstruction/Occlusion
2
2
Bacterial Infection
2
2
Chest Pain
2
2
Dyspnea
2
2
Respiratory Distress
2
2
Tachycardia
1
1
Paralysis
1
1
Low Blood Pressure/ Hypotension
1
1
Failure of Implant
1
1
Edema
1
1
Extravasation
1
1
Fever
1
1
Cardiac Arrest
1
1
Airway Obstruction
1
1
Apnea
1
1
Aspiration/Inhalation
1
1
Atrial Fibrillation
1
1
Wound Dehiscence
1
1
Abdominal Pain
1
1
Adult Respiratory Distress Syndrome
1
1
Needle Stick/Puncture
1
1
Cardiac Perforation
1
1
Pseudoaneurysm
1
1
Cardiac Tamponade
1
1
Distress
1
1
Partial thickness (Second Degree) Burn
1
1
Vascular Dissection
1
1
Loss of consciousness
1
1
Unspecified Respiratory Problem
1
1
Unspecified Tissue Injury
1
1
Swelling/ Edema
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
ConvaTec, Inc
II
Mar-21-2019
2
Cook Inc.
II
Nov-21-2019
3
Santanello Surgical LLC
II
Aug-09-2019
4
Teleflex Medical
II
Feb-16-2019
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