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TPLC
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show TPLC since
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Device
filter, infusion line
Product Code
FPB
Regulation Number
880.5440
Device Class
2
Premarket Reviews
Manufacturer
Decision
BAXTER HEALTHCARE CORP.
SUBSTANTIALLY EQUIVALENT
1
MERCK MILLIPORE LTD.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
67
67
2015
26
26
2016
95
95
2017
53
53
2018
35
35
2019
31
31
2020
18
18
2021
160
160
2022
36
36
2023
39
39
2024
24
24
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fluid/Blood Leak
378
378
Crack
74
74
Leak/Splash
53
53
Disconnection
26
26
Break
15
15
Hole In Material
12
12
No Flow
12
12
Device Contamination with Chemical or Other Material
10
10
Material Puncture/Hole
10
10
Obstruction of Flow
9
9
Improper Flow or Infusion
7
7
Insufficient Information
7
7
Adverse Event Without Identified Device or Use Problem
6
6
Reflux within Device
6
6
Defective Component
5
5
Backflow
5
5
Infusion or Flow Problem
5
5
Defective Device
4
4
Complete Blockage
4
4
Fracture
4
4
Material Separation
4
4
Loose or Intermittent Connection
3
3
Occlusion Within Device
3
3
Device Damaged Prior to Use
3
3
Difficult to Flush
3
3
Air Leak
3
3
Filtration Problem
3
3
Gas/Air Leak
2
2
Detachment of Device or Device Component
2
2
Device Operates Differently Than Expected
2
2
Pressure Problem
2
2
Protective Measures Problem
2
2
Component(s), broken
2
2
Detachment Of Device Component
2
2
Material Discolored
2
2
Insufficient Flow or Under Infusion
2
2
Increase in Pressure
2
2
Failure to Prime
2
2
Nonstandard Device
1
1
Improper or Incorrect Procedure or Method
1
1
Product Quality Problem
1
1
Failure to Deliver
1
1
Tear, Rip or Hole in Device Packaging
1
1
Cut In Material
1
1
Failure to Disconnect
1
1
Separation Failure
1
1
Unintended Ejection
1
1
Restricted Flow rate
1
1
Contamination
1
1
Burst Container or Vessel
1
1
Therapeutic or Diagnostic Output Failure
1
1
Material Integrity Problem
1
1
Mechanics Altered
1
1
Device Packaging Compromised
1
1
Patient-Device Incompatibility
1
1
Chemical Spillage
1
1
Connection Problem
1
1
Contamination of Device Ingredient or Reagent
1
1
Audible Prompt/Feedback Problem
1
1
Priming Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
202
202
No Consequences Or Impact To Patient
171
171
No Known Impact Or Consequence To Patient
133
133
Insufficient Information
18
18
No Information
11
11
No Patient Involvement
8
8
Low Blood Pressure/ Hypotension
8
8
Dyspnea
7
7
Underdose
6
6
Therapeutic Response, Decreased
6
6
Blood Loss
5
5
Abdominal Pain
5
5
Burning Sensation
5
5
Nausea
4
4
Respiratory Distress
3
3
Hot Flashes/Flushes
3
3
Hypoglycemia
3
3
Reaction
3
3
Low Oxygen Saturation
3
3
No Code Available
3
3
Unspecified Infection
2
2
Tachycardia
2
2
Thrombus
1
1
Urinary Retention
1
1
Venipuncture
1
1
Loss of Vision
1
1
Inflammation
1
1
Hypopyon
1
1
Bacterial Infection
1
1
Endophthalmitis
1
1
Hyperglycemia
1
1
High Blood Pressure/ Hypertension
1
1
Hyperthermia
1
1
Patient Problem/Medical Problem
1
1
High Pulmonary Arterial Wedge Pressure
1
1
Therapy/non-surgical treatment, additional
1
1
Unknown (for use when the patient's condition is not known)
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Halyard Health, Inc
II
Mar-30-2018
2
Pall Life Sciences Puerto Rico Llc
II
Jun-30-2011
3
Smiths Medical ASD Inc.
II
Apr-21-2021
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