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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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
  1.  K181782  Medline Reinforced Epidural Catheter
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 27 27

Device Problems MDRs with this Device Problem Events in those MDRs
Break 742 742
Obstruction of Flow 84 84
Detachment of Device or Device Component 66 66
Difficult to Advance 63 63
Fluid/Blood Leak 62 62
No Flow 47 47
Material Twisted/Bent 39 39
Failure to Advance 25 25
Material Separation 23 23
Difficult to Remove 18 18
Physical Resistance/Sticking 18 18
Adverse Event Without Identified Device or Use Problem 18 18
Material Split, Cut or Torn 17 17
Material Fragmentation 17 17
Disconnection 11 11
Crack 10 10
Unsealed Device Packaging 10 10
Fracture 9 9
Leak/Splash 9 9
Stretched 8 8
Material Integrity Problem 7 7
Activation, Positioning or Separation Problem 7 7
Shipping Damage or Problem 5 5
Burst Container or Vessel 5 5
Loose or Intermittent Connection 4 4
Defective Device 4 4
Component Missing 4 4
Packaging Problem 4 4
Material Too Soft/Flexible 3 3
Premature Separation 3 3
Entrapment of Device 3 3
Material Rupture 3 3
Device Damaged Prior to Use 3 3
Product Quality Problem 3 3
Material Puncture/Hole 2 2
Defective Component 2 2
Complete Blockage 2 2
Contamination 2 2
Flushing Problem 2 2
Separation Problem 2 2
Mechanical Jam 2 2
Material Deformation 2 2
Device Dislodged or Dislocated 2 2
Device Contamination with Body Fluid 2 2
Connection Problem 2 2
Patient-Device Incompatibility 1 1
Contamination /Decontamination Problem 1 1
Difficult to Open or Close 1 1
Device Markings/Labelling Problem 1 1
Device Damaged by Another Device 1 1
Failure to Deliver 1 1
Tear, Rip or Hole in Device Packaging 1 1
Dull, Blunt 1 1
Failure to Disconnect 1 1
Structural Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Pressure Problem 1 1
Device Handling Problem 1 1
Patient Device Interaction Problem 1 1
Migration 1 1
Sharp Edges 1 1
Device Fell 1 1
Difficult to Flush 1 1
Delivered as Unsterile Product 1 1
Device Emits Odor 1 1
Corroded 1 1
Positioning Failure 1 1
Unraveled Material 1 1
Improper or Incorrect Procedure or Method 1 1
Difficult to Insert 1 1
Peeled/Delaminated 1 1
Off-Label Use 1 1
Pumping Stopped 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 526 526
No Clinical Signs, Symptoms or Conditions 279 279
No Consequences Or Impact To Patient 233 233
Foreign Body In Patient 77 77
No Information 62 62
Insufficient Information 40 40
Not Applicable 33 33
Device Embedded In Tissue or Plaque 25 25
No Known Impact Or Consequence To Patient 23 23
Pain 14 14
Unspecified Infection 7 7
Needle Stick/Puncture 7 7
Headache 4 4
Bacterial Infection 3 3
Discomfort 3 3
Swelling/ Edema 3 3
No Code Available 3 3
Inadequate Pain Relief 2 2
Patient Problem/Medical Problem 2 2
Embolism/Embolus 2 2
Hematoma 2 2
Hemorrhage/Bleeding 2 2
Spinal Column Injury 2 2
Tachycardia 1 1
Vomiting 1 1
Perforation 1 1
Sepsis 1 1
Muscle Weakness 1 1
Neuropathy 1 1
Pulmonary Embolism 1 1
Abscess 1 1
Awareness during Anaesthesia 1 1
Hypersensitivity/Allergic reaction 1 1
Burn(s) 1 1
Cellulitis 1 1
Cerebrospinal Fluid Leakage 1 1
Purulent Discharge 1 1
Dyspnea 1 1
Fever 1 1
Respiratory Insufficiency 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Unspecified Tissue Injury 1 1
Fungal Infection 1 1
Low Oxygen Saturation 1 1
Sedation 1 1
Distress 1 1
Convulsion/Seizure 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 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
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