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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device port & catheter, implanted, subcutaneous, intravascular
Regulation Description Subcutaneous, implanted, intravascular infusion port and catheter.
Product CodeLJT
Regulation Number 880.5965
Device Class 2


Premarket Reviews
ManufacturerDecision
ANGIODYNAMICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BARD ACCESS SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BARD PERIPHERAL VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 959 959
2021 1285 1285
2022 1334 1334
2023 1225 1225
2024 1897 1897
2025 216 216

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 2506 2506
Adverse Event Without Identified Device or Use Problem 1564 1564
Fluid/Blood Leak 993 993
Material Separation 982 982
Deformation Due to Compressive Stress 841 841
Migration 681 681
Suction Problem 579 579
Difficult to Flush 475 475
Naturally Worn 466 466
Obstruction of Flow 402 402
Detachment of Device or Device Component 197 197
Difficult to Remove 184 184
Stretched 168 168
Material Protrusion/Extrusion 167 167
Disconnection 151 151
Material Puncture/Hole 119 119
Break 118 118
Failure to Advance 113 113
Expulsion 105 105
Air/Gas in Device 102 102
Difficult to Insert 100 100
Material Deformation 86 86
Material Integrity Problem 83 83
Blocked Connection 78 78
Migration or Expulsion of Device 77 77
Component Missing 77 77
Device Damaged Prior to Use 76 76
Physical Resistance/Sticking 72 72
Material Split, Cut or Torn 71 71
Improper or Incorrect Procedure or Method 70 70
Defective Component 68 68
Difficult or Delayed Separation 61 61
Dent in Material 60 60
Failure to Infuse 58 58
Material Twisted/Bent 55 55
Leak/Splash 52 52
Tear, Rip or Hole in Device Packaging 52 52
Device Appears to Trigger Rejection 49 49
Entrapment of Device 41 41
Device Tipped Over 39 39
Loose or Intermittent Connection 39 39
Insufficient Information 39 39
Unraveled Material 35 35
Crack 35 35
Device Contaminated During Manufacture or Shipping 34 34
Component Misassembled 33 33
Loss of or Failure to Bond 31 31
Device Dislodged or Dislocated 31 31
Infusion or Flow Problem 30 30
Packaging Problem 30 30

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3358 3358
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 673 673
Unspecified Infection 550 550
Pain 403 403
No Consequences Or Impact To Patient 365 365
Thrombosis/Thrombus 318 318
Insufficient Information 275 275
Swelling/ Edema 270 270
Extravasation 206 206
Arrhythmia 185 185
Foreign Body In Patient 175 175
Bacterial Infection 173 173
Sepsis 98 98
Skin Erosion 87 87
Injury 84 84
No Patient Involvement 66 66
Device Embedded In Tissue or Plaque 62 62
Embolism/Embolus 49 49
Discomfort 49 49
Chest Pain 46 46
Pneumothorax 43 43
Pulmonary Embolism 38 38
Failure of Implant 36 36
No Known Impact Or Consequence To Patient 36 36
Hemorrhage/Bleeding 35 35
Fever 34 34
Erythema 32 32
Swelling 29 29
Infiltration into Tissue 28 28
Hypersensitivity/Allergic reaction 27 27
Neck Pain 25 25
Inflammation 24 24
Phlebitis 23 23
Hematoma 21 21
Cellulitis 21 21
Bruise/Contusion 20 20
Burning Sensation 19 19
Thrombus 19 19
Implant Pain 18 18
Itching Sensation 17 17
Fungal Infection 17 17
Rash 16 16
Skin Inflammation/ Irritation 14 14
Wound Dehiscence 14 14
Septic Shock 13 13
Tachycardia 13 13
Obstruction/Occlusion 12 12
Perforation of Vessels 12 12
Dyspnea 12 12
Air Embolism 10 10

Recalls
Manufacturer Recall Class Date Posted
1 Angiodynamics Inc. (Navilyst Medical Inc.) II Apr-21-2021
2 Angiodynamics, Inc. II Oct-25-2022
3 Bard Peripheral Vascular Inc II May-10-2021
4 Bard Peripheral Vascular Inc II May-12-2020
5 Bard Peripheral Vascular Inc II Mar-26-2020
6 Medical Components, Inc dba MedComp II Mar-08-2021
7 Smiths Medical ASD Inc. II Jul-04-2020
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