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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
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
Backflow
5
5
Defective Component
5
5
Infusion or Flow Problem
5
5
Filtration Problem
4
4
Fracture
4
4
Complete Blockage
4
4
Defective Device
4
4
Material Separation
4
4
Device Damaged Prior to Use
3
3
Difficult to Flush
3
3
Loose or Intermittent Connection
3
3
Occlusion Within Device
3
3
Air Leak
3
3
Detachment Of Device Component
2
2
Insufficient Flow or Under Infusion
2
2
Increase in Pressure
2
2
Device Operates Differently Than Expected
2
2
Protective Measures Problem
2
2
Component(s), broken
2
2
Gas/Air Leak
2
2
Detachment of Device or Device Component
2
2
Material Discolored
2
2
Failure to Prime
2
2
Pressure Problem
2
2
Product Quality Problem
1
1
Unintended Ejection
1
1
Contamination
1
1
Chemical Spillage
1
1
Contamination of Device Ingredient or Reagent
1
1
Device Packaging Compromised
1
1
Failure to Deliver
1
1
Nonstandard Device
1
1
Priming Problem
1
1
Connection Problem
1
1
Material Integrity Problem
1
1
Failure to Disconnect
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
Therapeutic Response, Decreased
6
6
Underdose
6
6
Abdominal Pain
5
5
Blood Loss
5
5
Burning Sensation
5
5
Nausea
4
4
Respiratory Distress
3
3
No Code Available
3
3
Hypoglycemia
3
3
Reaction
3
3
Tachycardia
3
3
Hot Flashes/Flushes
3
3
Low Oxygen Saturation
3
3
High Blood Pressure/ Hypertension
2
2
Unspecified Infection
2
2
Patient Problem/Medical Problem
1
1
Hypopyon
1
1
Venipuncture
1
1
High Pulmonary Arterial Wedge Pressure
1
1
Therapy/non-surgical treatment, additional
1
1
Endophthalmitis
1
1
Inflammation
1
1
Fever
1
1
Urinary Retention
1
1
Hyperglycemia
1
1
Hyperthermia
1
1
Bacterial Infection
1
1
Loss of Vision
1
1
Thrombus
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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