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TPLC
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Device
gastrointestinal tubes with enteral specific connectors
Definition
To facilitate enteral specific connections.
Product Code
PIF
Regulation Number
876.5980
Device Class
2
Premarket Reviews
Manufacturer
Decision
ANHUI TIANKANG MEDICAL TECHNOLOGY CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
CAIR LGL
SUBSTANTIALLY EQUIVALENT
2
CARDINAL HEALTH
SUBSTANTIALLY EQUIVALENT
2
CEDIC S.R.L.
SUBSTANTIALLY EQUIVALENT
2
GBUK GROUP LTD
SUBSTANTIALLY EQUIVALENT
1
KB MEDICAL (GROUP) INC.
SUBSTANTIALLY EQUIVALENT
1
MEDLINE INDUSTRIES, INC.
SUBSTANTIALLY EQUIVALENT
1
MOSS TUBES, INC.
SUBSTANTIALLY EQUIVALENT
1
MPS MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
ROCKFIELD MEDICAL
SUBSTANTIALLY EQUIVALENT
2
SYNCRO MEDICAL INNOVATIONS, INC.
SUBSTANTIALLY EQUIVALENT
1
SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS
1
THREE CIRCLES CONSULTING LIMITED
SUBSTANTIALLY EQUIVALENT
1
U DELIVER MEDICAL, LLC
SUBSTANTIALLY EQUIVALENT
1
VESCO MEDICAL
SUBSTANTIALLY EQUIVALENT
1
VESCO MEDICAL LLC
SUBSTANTIALLY EQUIVALENT
1
VONCO PRODUCTS
SUBSTANTIALLY EQUIVALENT
2
1. K210971
EnteraLoc Flow
2. K223683
EnteraLoc Flow
WILSON-COOK MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT - WITH DRUG
1
XERIDIEM MEDICAL DEVICES, A SPECTRUM PLASTICS GROUP COMPANY
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
28
28
2020
70
70
2021
89
89
2022
77
77
2023
96
96
2024
23
23
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fluid/Blood Leak
66
66
Detachment of Device or Device Component
60
60
Adverse Event Without Identified Device or Use Problem
29
29
Obstruction of Flow
28
28
Break
22
22
Device Dislodged or Dislocated
19
19
Unintended Deflation
18
18
Complete Blockage
13
13
Crack
13
13
Fracture
10
10
Material Twisted/Bent
10
10
Material Rupture
9
9
Suction Problem
9
9
Leak/Splash
8
8
Physical Resistance/Sticking
8
8
Unintended Movement
7
7
Burst Container or Vessel
7
7
Use of Device Problem
7
7
Material Separation
6
6
Difficult to Remove
6
6
Decrease in Suction
6
6
Material Puncture/Hole
6
6
Migration
4
4
Material Split, Cut or Torn
4
4
Difficult to Advance
4
4
No Apparent Adverse Event
3
3
Suction Failure
3
3
Material Integrity Problem
3
3
Deflation Problem
3
3
Malposition of Device
3
3
Contamination /Decontamination Problem
2
2
Device Markings/Labelling Problem
2
2
Defective Device
2
2
Failure to Analyze Signal
2
2
Improper or Incorrect Procedure or Method
2
2
Material Discolored
2
2
Disconnection
2
2
Product Quality Problem
2
2
Insufficient Information
2
2
Protective Measures Problem
2
2
Therapeutic or Diagnostic Output Failure
1
1
Noise, Audible
1
1
Patient Device Interaction Problem
1
1
Difficult to Open or Close
1
1
No Flow
1
1
Device Contamination with Chemical or Other Material
1
1
Device Contaminated During Manufacture or Shipping
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Device Appears to Trigger Rejection
1
1
Inadequate Instructions for Healthcare Professional
1
1
Loose or Intermittent Connection
1
1
Nonstandard Device
1
1
Unsealed Device Packaging
1
1
No Display/Image
1
1
Contamination
1
1
Fitting Problem
1
1
Component Missing
1
1
Stretched
1
1
Device Displays Incorrect Message
1
1
Structural Problem
1
1
Separation Failure
1
1
Connection Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
219
219
No Consequences Or Impact To Patient
37
37
Insufficient Information
22
22
No Known Impact Or Consequence To Patient
20
20
Unspecified Infection
14
14
Vomiting
10
10
Low Oxygen Saturation
8
8
Aspiration/Inhalation
8
8
Foreign Body In Patient
8
8
Bradycardia
6
6
Pneumothorax
5
5
Perforation
4
4
Bowel Perforation
4
4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
4
4
No Code Available
3
3
No Patient Involvement
3
3
Feeding Problem
3
3
Hemorrhage/Bleeding
2
2
Adult Respiratory Distress Syndrome
2
2
Death
2
2
Sepsis
2
2
Septic Shock
2
2
Internal Organ Perforation
2
2
Pain
2
2
No Information
2
2
Fluid Discharge
2
2
Choking
2
2
Abdominal Distention
2
2
Skin Inflammation/ Irritation
2
2
Unintended Extubation
1
1
Multiple Organ Failure
1
1
Respiratory Arrest
1
1
Renal Impairment
1
1
Cardiac Arrest
1
1
Strangulation
1
1
Respiratory Failure
1
1
Missed Dose
1
1
Viral Infection
1
1
Peritonitis
1
1
Discomfort
1
1
Skin Inflammation
1
1
Dehydration
1
1
Purulent Discharge
1
1
Dyspnea
1
1
Edema
1
1
Abdominal Pain
1
1
Erosion
1
1
Hypersensitivity/Allergic reaction
1
1
Low Blood Pressure/ Hypotension
1
1
Failure of Implant
1
1
Inflammation
1
1
Liver Damage/Dysfunction
1
1
Necrosis
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Boston Scientific Corporation
II
Apr-11-2024
2
Boston Scientific Corporation
II
Feb-16-2024
3
GETINGE US SALES LLC
III
Apr-25-2019
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