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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
Product CodeLJT
Regulation Number 880.5965
Device Class 2


Premarket Reviews
ManufacturerDecision
ANGIODYNAMICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BARD PERIPHERAL VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 765 765
2020 959 959
2021 1285 1285
2022 1334 1334
2023 1225 1225
2024 1138 1138

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 2303 2303
Adverse Event Without Identified Device or Use Problem 1231 1231
Fluid/Blood Leak 1008 1008
Material Separation 884 884
Deformation Due to Compressive Stress 731 731
Migration 595 595
Suction Problem 571 571
Difficult to Flush 423 423
Naturally Worn 420 420
Obstruction of Flow 377 377
Break 302 302
Detachment of Device or Device Component 216 216
Difficult to Remove 160 160
Material Protrusion/Extrusion 159 159
Stretched 150 150
Disconnection 143 143
Component Missing 131 131
Defective Component 125 125
Material Puncture/Hole 111 111
Failure to Advance 99 99
Material Deformation 97 97
Air/Gas in Device 95 95
Migration or Expulsion of Device 93 93
Failure to Infuse 87 87
Difficult to Insert 84 84
Appropriate Term/Code Not Available 81 81
Expulsion 80 80
Material Integrity Problem 74 74
Blocked Connection 73 73
Improper or Incorrect Procedure or Method 70 70
Material Split, Cut or Torn 63 63
Dent in Material 60 60
Physical Resistance/Sticking 60 60
Leak/Splash 57 57
Tear, Rip or Hole in Device Packaging 56 56
Difficult or Delayed Separation 55 55
Material Twisted/Bent 50 50
Device Damaged Prior to Use 49 49
Device Dislodged or Dislocated 44 44
Crack 43 43
Device Appears to Trigger Rejection 43 43
Entrapment of Device 42 42
Device Tipped Over 36 36
Loose or Intermittent Connection 34 34
Infusion or Flow Problem 30 30
Component Misassembled 30 30
Material Frayed 30 30
Insufficient Information 29 29
Device Contamination with Chemical or Other Material 28 28
Device Contaminated During Manufacture or Shipping 26 26

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2974 2974
No Consequences Or Impact To Patient 708 708
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 593 593
Pain 383 383
Unspecified Infection 342 342
Insufficient Information 266 266
Swelling/ Edema 217 217
Extravasation 208 208
Arrhythmia 184 184
Injury 183 183
Foreign Body In Patient 179 179
Thrombosis/Thrombus 177 177
No Patient Involvement 150 150
Bacterial Infection 145 145
Device Embedded In Tissue or Plaque 90 90
Sepsis 90 90
No Known Impact Or Consequence To Patient 89 89
Skin Erosion 67 67
Swelling 59 59
Embolism 55 55
Embolism/Embolus 46 46
Discomfort 45 45
Pneumothorax 43 43
Chest Pain 42 42
Failure of Implant 35 35
Pulmonary Embolism 35 35
Erythema 34 34
Infiltration into Tissue 29 29
Neck Pain 28 28
Hemorrhage/Bleeding 27 27
Thrombus 25 25
Inflammation 24 24
Hypersensitivity/Allergic reaction 23 23
Fever 23 23
Phlebitis 23 23
Hematoma 22 22
Burning Sensation 20 20
Bruise/Contusion 19 19
Itching Sensation 19 19
Cellulitis 18 18
Fungal Infection 17 17
Rash 16 16
Implant Pain 15 15
Perforation of Vessels 15 15
Wound Dehiscence 14 14
Edema 12 12
Death 11 11
Septic Shock 10 10
No Information 10 10
Tachycardia 10 10

Recalls
Manufacturer Recall Class Date Posted
1 Angiodynamics Inc. (Navilyst Medical Inc.) II Apr-21-2021
2 Angiodynamics Inc. (Navilyst Medical Inc.) II Nov-21-2019
3 Angiodynamics, Inc. II Oct-25-2022
4 Bard Peripheral Vascular Inc II May-10-2021
5 Bard Peripheral Vascular Inc II May-12-2020
6 Bard Peripheral Vascular Inc II Mar-26-2020
7 Bard Peripheral Vascular Inc II Nov-27-2019
8 Bard Peripheral Vascular Inc II Jul-25-2019
9 Medical Components, Inc dba MedComp II Mar-08-2021
10 Smiths Medical ASD Inc. II Jul-04-2020
11 Smiths Medical ASD Inc. II Oct-24-2019
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