• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device catheter, conduction, anesthetic
Product CodeBSO
Regulation Number 868.5120
Device Class 2


Premarket Reviews
ManufacturerDecision
B. BRAUN MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
CIMPAX APS
  SUBSTANTIALLY EQUIVALENT 1
EPIMED INTERNATIONAL INC.
  SUBSTANTIALLY EQUIVALENT 1
HK SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
TELEFLEX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 779 779
2020 159 159
2021 146 146
2022 135 135
2023 80 80
2024 93 93

Device Problems MDRs with this Device Problem Events in those MDRs
Break 756 756
Obstruction of Flow 85 85
Fluid/Blood Leak 68 68
Detachment of Device or Device Component 66 66
Difficult to Advance 66 66
Material Twisted/Bent 49 49
No Flow 47 47
Material Separation 40 40
Failure to Advance 25 25
Physical Resistance/Sticking 20 20
Adverse Event Without Identified Device or Use Problem 19 19
Difficult to Remove 19 19
Material Fragmentation 18 18
Material Split, Cut or Torn 17 17
Disconnection 12 12
Leak/Splash 11 11
Crack 10 10
Unsealed Device Packaging 10 10
Fracture 9 9
Stretched 8 8
Activation, Positioning or Separation Problem 7 7
Material Integrity Problem 7 7
Burst Container or Vessel 5 5
Material Rupture 5 5
Defective Device 5 5
Shipping Damage or Problem 5 5
Loose or Intermittent Connection 4 4
Packaging Problem 4 4
Component Missing 4 4
Premature Separation 3 3
Material Too Soft/Flexible 3 3
Product Quality Problem 3 3
Unraveled Material 3 3
Entrapment of Device 3 3
Material Puncture/Hole 3 3
Complete Blockage 3 3
Device Damaged Prior to Use 3 3
Dull, Blunt 2 2
Separation Problem 2 2
Mechanical Jam 2 2
Contamination 2 2
Defective Component 2 2
Unintended Movement 2 2
Gas/Air Leak 2 2
Mechanical Problem 2 2
Connection Problem 2 2
Flushing Problem 2 2
Device Dislodged or Dislocated 2 2
Material Deformation 2 2
Device Contamination with Body Fluid 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 526 526
No Clinical Signs, Symptoms or Conditions 316 316
No Consequences Or Impact To Patient 233 233
Foreign Body In Patient 94 94
No Information 62 62
Insufficient Information 46 46
Not Applicable 33 33
Device Embedded In Tissue or Plaque 25 25
No Known Impact Or Consequence To Patient 23 23
Pain 17 17
Needle Stick/Puncture 10 10
Unspecified Infection 7 7
Headache 4 4
Inadequate Pain Relief 3 3
Bacterial Infection 3 3
Swelling/ Edema 3 3
No Code Available 3 3
Discomfort 3 3
Hemorrhage/Bleeding 2 2
Paresthesia 2 2
Spinal Column Injury 2 2
Embolism/Embolus 2 2
Hematoma 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Patient Problem/Medical Problem 2 2
Cellulitis 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Purulent Discharge 1 1
Burn(s) 1 1
Fever 1 1
Perforation 1 1
Vomiting 1 1
Muscle Weakness 1 1
Awareness during Anaesthesia 1 1
Dyspnea 1 1
Abscess 1 1
Sedation 1 1
Tachycardia 1 1
Unspecified Tissue Injury 1 1
Fungal Infection 1 1
Cerebrospinal Fluid Leakage 1 1
Convulsion/Seizure 1 1
Sepsis 1 1
Decreased Sensitivity 1 1
Hypersensitivity/Allergic reaction 1 1
Neuropathy 1 1
Respiratory Insufficiency 1 1
Low Oxygen Saturation 1 1
Pulmonary Embolism 1 1
Distress 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 Epimed International II Aug-18-2021
5 Epimed International, Inc. II Mar-18-2021
6 Epimed International, Inc. II Jul-24-2019
-
-