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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, conduction, anesthetic
Product CodeBSO
Regulation Number 868.5120
Device Class 2


Premarket Reviews
ManufacturerDecision
CIMPAX APS
  SUBSTANTIALLY EQUIVALENT 1
EPIMED INTERNATIONAL INC.
  SUBSTANTIALLY EQUIVALENT 1
HK SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
IMEDICOM CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
PAJUNK GMBH MEDIZINTECHNOLOGIE
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 80 80
2019 779 779
2020 159 159
2021 145 145
2022 138 138
2023 18 18

Device Problems MDRs with this Device Problem Events in those MDRs
Break 736 736
Obstruction of Flow 81 81
Detachment of Device or Device Component 70 70
Fluid/Blood Leak 57 57
Difficult to Advance 55 55
No Flow 46 46
Material Twisted/Bent 39 39
Adverse Event Without Identified Device or Use Problem 25 25
Failure to Advance 24 24
Physical Resistance/Sticking 21 21
Material Split, Cut or Torn 19 19
Difficult to Remove 17 17
Material Separation 15 15
Material Fragmentation 15 15
Disconnection 13 13
Fracture 12 12
Leak/Splash 12 12
Unsealed Device Packaging 10 10
Crack 10 10
Device Handling Problem 8 8
Activation, Positioning or Separation Problem 7 7
Premature Separation 7 7
Defective Device 6 6
Material Integrity Problem 6 6
Stretched 6 6
Shipping Damage or Problem 5 5
Burst Container or Vessel 5 5
Component Missing 5 5
Device Damaged by Another Device 4 4
Device Dislodged or Dislocated 4 4
Packaging Problem 4 4
Loose or Intermittent Connection 4 4
Product Quality Problem 3 3
Entrapment of Device 3 3
Material Rupture 3 3
Device Damaged Prior to Use 3 3
Device Issue 3 3
Device Contamination with Body Fluid 2 2
Connection Problem 2 2
Patient Device Interaction Problem 2 2
Material Too Soft/Flexible 2 2
Material Deformation 2 2
Mechanical Jam 2 2
Complete Blockage 2 2
Kinked 2 2
Contamination 2 2
Flushing Problem 2 2
Material Puncture/Hole 2 2
Mechanical Problem 2 2
Separation Problem 2 2
Delivered as Unsterile Product 1 1
Device Emits Odor 1 1
Peeled/Delaminated 1 1
Off-Label Use 1 1
Retraction Problem 1 1
Unraveled Material 1 1
Use of Device Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Difficult to Flush 1 1
Difficult to Insert 1 1
Detachment Of Device Component 1 1
Cross Reactivity 1 1
Device Contamination with Chemical or Other Material 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Difficult to Open or Close 1 1
Sharp Edges 1 1
Device Fell 1 1
Positioning Problem 1 1
Pressure Problem 1 1
Appropriate Term/Code Not Available 1 1
Contamination /Decontamination Problem 1 1
Physical Resistance 1 1
Failure to Deliver 1 1
Tear, Rip or Hole in Device Packaging 1 1
Structural Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 526 526
No Consequences Or Impact To Patient 265 265
No Clinical Signs, Symptoms or Conditions 224 224
No Information 76 76
Foreign Body In Patient 68 68
Not Applicable 33 33
No Known Impact Or Consequence To Patient 31 31
Insufficient Information 29 29
Device Embedded In Tissue or Plaque 27 27
Pain 14 14
Unspecified Infection 7 7
No Code Available 7 7
Awareness during Anaesthesia 5 5
Needle Stick/Puncture 5 5
Discomfort 3 3
Bacterial Infection 3 3
Death 3 3
Headache 3 3
Patient Problem/Medical Problem 3 3
Swelling/ Edema 3 3
Embolism/Embolus 2 2
Hematoma 2 2
Hemorrhage/Bleeding 2 2
Fever 2 2
Cardiac Arrest 2 2
Toxicity 2 2
Inadequate Pain Relief 2 2
Reaction 2 2
Spinal Column Injury 2 2
Tachycardia 1 1
Tissue Damage 1 1
Vasoconstriction 1 1
Vomiting 1 1
Sepsis 1 1
Distress 1 1
Fungal Infection 1 1
Post Operative Wound Infection 1 1
Sedation 1 1
Low Oxygen Saturation 1 1
Underdose 1 1
Cardiopulmonary Arrest 1 1
Cellulitis 1 1
Purulent Discharge 1 1
Dyspnea 1 1
Burn(s) 1 1
Pulmonary Embolism 1 1
Abscess 1 1
Fistula 1 1
Muscle Weakness 1 1
Nausea 1 1
Hypersensitivity/Allergic reaction 1 1
Respiratory Insufficiency 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Unspecified Tissue Injury 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Thromboembolism 1 1
Convulsion/Seizure 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Arrow International Inc II Jun-05-2020
2 Arrow International Inc II Feb-14-2020
3 Arrow International Inc II Jan-24-2020
4 B. Braun Medical, Inc. II Oct-01-2018
5 Epimed International II Aug-18-2021
6 Epimed International, Inc. II Mar-18-2021
7 Epimed International, Inc. II Jul-24-2019
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