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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
Device catheter, urethral
Product CodeGBM
Regulation Number 876.5130
Device Class 2


Premarket Reviews
ManufacturerDecision
B. BRAUN MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
COLOPLAST
  SUBSTANTIALLY EQUIVALENT 4
CONVATEC
  SUBSTANTIALLY EQUIVALENT 1
CONVATEC LIMITED
  SUBSTANTIALLY EQUIVALENT 1
F&S MEDICAL SOLUTIONS, LLC
  SUBSTANTIALLY EQUIVALENT 1
HAKKI MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT - KIT 1
HANGZHOU BEVER MEDICAL DEVICES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HANGZHOU JIMUSHI MEDITECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HOLLISTER INCORPORATED
  SUBSTANTIALLY EQUIVALENT 3
TELEFLEX MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT - KIT 1

MDR Year MDR Reports MDR Events
2019 148 148
2020 144 144
2021 102 102
2022 283 283
2023 202 202
2024 273 273

Device Problems MDRs with this Device Problem Events in those MDRs
Tear, Rip or Hole in Device Packaging 288 288
Adverse Event Without Identified Device or Use Problem 129 129
Device Misassembled During Manufacturing /Shipping 67 67
Difficult to Open or Remove Packaging Material 65 65
Sharp Edges 55 55
Delivered as Unsterile Product 54 54
Difficult to Remove 42 42
Biocompatibility 34 34
Patient Device Interaction Problem 33 33
Break 33 33
Fluid/Blood Leak 33 33
Deflation Problem 27 27
Material Puncture/Hole 25 25
Product Quality Problem 25 25
Contamination /Decontamination Problem 25 25
Packaging Problem 23 23
Unsealed Device Packaging 21 21
Material Deformation 20 20
Material Invagination 19 19
Decrease in Pressure 18 18
Partial Blockage 17 17
Difficult to Open or Close 16 16
Difficult to Insert 14 14
Material Split, Cut or Torn 14 14
Burst Container or Vessel 13 13
Device Damaged Prior to Use 13 13
Device Markings/Labelling Problem 12 12
Device Handling Problem 12 12
Insufficient Information 10 10
Inaccurate Flow Rate 10 10
Entrapment of Device 9 9
Leak/Splash 8 8
Material Too Rigid or Stiff 8 8
Device Contamination with Chemical or Other Material 8 8
Dent in Material 8 8
Detachment of Device or Device Component 7 7
Material Twisted/Bent 7 7
Appropriate Term/Code Not Available 6 6
Manufacturing, Packaging or Shipping Problem 6 6
Component Misassembled 6 6
Failure to Infuse 6 6
Defective Device 6 6
Fracture 5 5
Material Fragmentation 5 5
Inflation Problem 3 3
Inadequate Instructions for Healthcare Professional 3 3
Material Rupture 3 3
Use of Device Problem 3 3
Obstruction of Flow 3 3
Activation, Positioning or Separation Problem 3 3
Physical Resistance/Sticking 3 3
Illegible Information 3 3
Premature Separation 2 2
Device Fell 2 2
Improper Chemical Reaction 2 2
Device Contaminated During Manufacture or Shipping 2 2
Device Dislodged or Dislocated 2 2
Defective Component 2 2
Component Missing 2 2
Inadequacy of Device Shape and/or Size 2 2
Off-Label Use 2 2
Nonstandard Device 2 2
Misassembled 1 1
Calcified 1 1
Degraded 1 1
Material Separation 1 1
Device Slipped 1 1
Inadequate or Insufficient Training 1 1
Improper or Incorrect Procedure or Method 1 1
No Flow 1 1
Material Integrity Problem 1 1
Material Too Soft/Flexible 1 1
Scratched Material 1 1
Device Sensing Problem 1 1
Structural Problem 1 1
Separation Failure 1 1
Patient-Device Incompatibility 1 1
Deformation Due to Compressive Stress 1 1
Separation Problem 1 1
Failure to Deflate 1 1
Wrong Label 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 568 568
Urinary Tract Infection 146 146
No Consequences Or Impact To Patient 128 128
No Patient Involvement 94 94
No Known Impact Or Consequence To Patient 58 58
Pain 48 48
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 44 44
Hemorrhage/Bleeding 35 35
Unspecified Tissue Injury 32 32
Hematuria 29 29
Discomfort 21 21
Unspecified Infection 19 19
Sepsis 16 16
Tissue Breakdown 13 13
Blood Loss 10 10
Patient Problem/Medical Problem 7 7
Insufficient Information 5 5
Foreign Body In Patient 5 5
No Code Available 5 5
Genital Bleeding 5 5
Injury 5 5
Bruise/Contusion 5 5
Exsanguination 4 4
Irritation 4 4
Burning Sensation 4 4
Urinary Retention 3 3
Perforation 3 3
Abrasion 3 3
Exposure to Body Fluids 3 3
Abdominal Pain 2 2
Fall 2 2
Rash 2 2
Local Reaction 2 2
Laceration(s) 2 2
Skin Irritation 2 2
Cancer 2 2
Kidney Infection 2 2
Device Embedded In Tissue or Plaque 2 2
No Information 2 2
Distress 2 2
Fungal Infection 2 2
Skin Tears 2 2
Fluid Discharge 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Localized Skin Lesion 1 1
Skin Inflammation/ Irritation 1 1
Drug Resistant Bacterial Infection 1 1
Swelling/ Edema 1 1
Renal Failure 1 1
Uremia 1 1
Pressure Sores 1 1
Coma 1 1
Loss of consciousness 1 1
Fever 1 1
Fistula 1 1
Hematoma 1 1
Itching Sensation 1 1
Hypersensitivity/Allergic reaction 1 1
Anemia 1 1
Bacterial Infection 1 1
Fainting 1 1
Cyst(s) 1 1
Purulent Discharge 1 1

Recalls
Manufacturer Recall Class Date Posted
1 C.R. Bard Inc II Sep-23-2021
2 Cardinal Health 200, LLC I Feb-16-2024
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