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TPLC
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show TPLC since
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2024
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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
HANGZHOU QIANTANG LONGYUE BIOTECHNOLOGY CO., LTD
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
34
34
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fluid/Blood Leak
382
382
Crack
75
75
Leak/Splash
57
57
Disconnection
26
26
Break
15
15
No Flow
12
12
Hole In Material
12
12
Device Contamination with Chemical or Other Material
10
10
Material Puncture/Hole
10
10
Obstruction of Flow
9
9
Insufficient Information
7
7
Improper Flow or Infusion
7
7
Adverse Event Without Identified Device or Use Problem
6
6
Reflux within Device
6
6
Infusion or Flow Problem
5
5
Backflow
5
5
Defective Component
5
5
Material Separation
4
4
Filtration Problem
4
4
Complete Blockage
4
4
Fracture
4
4
Defective Device
4
4
Occlusion Within Device
3
3
Loose or Intermittent Connection
3
3
Air Leak
3
3
Difficult to Flush
3
3
Device Damaged Prior to Use
3
3
Increase in Pressure
2
2
Device Operates Differently Than Expected
2
2
Protective Measures Problem
2
2
Detachment Of Device Component
2
2
Material Discolored
2
2
Gas/Air Leak
2
2
Insufficient Flow or Under Infusion
2
2
Detachment of Device or Device Component
2
2
Failure to Prime
2
2
Pressure Problem
2
2
Component(s), broken
2
2
Material Integrity Problem
1
1
Therapeutic or Diagnostic Output Failure
1
1
Burst Container or Vessel
1
1
Contamination
1
1
Failure to Disconnect
1
1
Improper or Incorrect Procedure or Method
1
1
Failure to Deliver
1
1
Chemical Spillage
1
1
Device Packaging Compromised
1
1
Patient-Device Incompatibility
1
1
Separation Failure
1
1
Unintended Ejection
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
211
211
No Consequences Or Impact To Patient
171
171
No Known Impact Or Consequence To Patient
133
133
Insufficient Information
19
19
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
Abdominal Pain
5
5
Blood Loss
5
5
Burning Sensation
5
5
Nausea
4
4
No Code Available
3
3
Respiratory Distress
3
3
Hypoglycemia
3
3
Reaction
3
3
Tachycardia
3
3
Hot Flashes/Flushes
3
3
Low Oxygen Saturation
3
3
Unspecified Infection
2
2
High Blood Pressure/ Hypertension
2
2
Patient Problem/Medical Problem
1
1
Therapy/non-surgical treatment, additional
1
1
Venipuncture
1
1
Hypopyon
1
1
High Pulmonary Arterial Wedge Pressure
1
1
Endophthalmitis
1
1
Inflammation
1
1
Fever
1
1
Urinary Retention
1
1
Hyperglycemia
1
1
Hyperthermia
1
1
Loss of Vision
1
1
Bacterial Infection
1
1
Unknown (for use when the patient's condition is not known)
1
1
Thrombus
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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