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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device tubing, pressure and accessories
Product CodeBYX
Regulation Number 868.5860
Device Class 1

MDR Year MDR Reports MDR Events
2014 9 9
2015 17 17
2016 19 19
2017 19 19
2018 12 12
2019 16 16
2020 32 32
2021 13 13
2022 10 10
2023 25 25
2024 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Crack 23 23
Detachment of Device or Device Component 21 21
Break 13 13
Component Falling 12 12
Adverse Event Without Identified Device or Use Problem 12 12
Detachment Of Device Component 11 11
Disconnection 11 11
Kinked 10 10
Peeled/Delaminated 9 9
Leak/Splash 8 8
Burst Container or Vessel 6 6
Material Twisted/Bent 6 6
Connection Problem 6 6
Gas/Air Leak 5 5
Corroded 5 5
Loose or Intermittent Connection 4 4
Use of Device Problem 4 4
Device Dislodged or Dislocated 4 4
Material Deformation 4 4
Material Split, Cut or Torn 4 4
Insufficient Information 3 3
Unintended Ejection 3 3
Electrical /Electronic Property Problem 2 2
Positioning Failure 2 2
Air Leak 2 2
Complete Blockage 2 2
Collapse 2 2
Improper or Incorrect Procedure or Method 2 2
Off-Label Use 2 2
Device Fell 2 2
Unintended Movement 2 2
Improper Flow or Infusion 2 2
No Flow 2 2
Positioning Problem 2 2
Patient-Device Incompatibility 2 2
Component Missing 2 2
Failure to Deliver 2 2
Device Issue 2 2
Obstruction of Flow 1 1
Increase in Pressure 1 1
Device Contamination with Chemical or Other Material 1 1
Human Factors Issue 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Device Operates Differently Than Expected 1 1
Device Damaged by Another Device 1 1
Pressure Problem 1 1
Infusion or Flow Problem 1 1
Material Integrity Problem 1 1
No Apparent Adverse Event 1 1
Appropriate Term/Code Not Available 1 1
Noise, Audible 1 1
Patient Device Interaction Problem 1 1
Material Puncture/Hole 1 1
Product Quality Problem 1 1
Tidal Volume Fluctuations 1 1
Unstable 1 1
Suction Problem 1 1
Material Perforation 1 1
Tube(s), defective 1 1
Misconnection 1 1
Moisture Damage 1 1
Occlusion Within Device 1 1
Device Emits Odor 1 1
Unintended Collision 1 1
Overheating of Device 1 1
Adaptor, failure of 1 1
Fire 1 1
Flaked 1 1
Fluid/Blood Leak 1 1
Material Fragmentation 1 1
Inflation Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 51 51
No Clinical Signs, Symptoms or Conditions 38 38
No Known Impact Or Consequence To Patient 29 29
No Patient Involvement 14 14
Low Oxygen Saturation 13 13
No Information 5 5
Insufficient Information 4 4
Injury 4 4
Death 4 4
Fall 4 4
Pain 3 3
Hypoxia 3 3
Numbness 3 3
Skin Tears 3 3
Burning Sensation 2 2
Bone Fracture(s) 2 2
Headache 2 2
Hematoma 2 2
Dyspnea 2 2
Bradycardia 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Patient Problem/Medical Problem 2 2
No Code Available 2 2
Cough 1 1
Skin Inflammation/ Irritation 1 1
Bruise/Contusion 1 1
Airway Obstruction 1 1
Aspiration/Inhalation 1 1
Asphyxia 1 1
Low Blood Pressure/ Hypotension 1 1
Paralysis 1 1
Pleural Effusion 1 1
Respiratory Distress 1 1
Weakness 1 1
Concussion 1 1
Unspecified Infection 1 1
Laceration(s) 1 1
Hip Fracture 1 1
Complaint, Ill-Defined 1 1
Chemical Exposure 1 1
Blood Loss 1 1
Superficial (First Degree) Burn 1 1
Chest Tightness/Pressure 1 1
Decreased Respiratory Rate 1 1

Recalls
Manufacturer Recall Class Date Posted
1 A M Systems Inc II Oct-16-2018
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