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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, urological
Product CodeKOD
Regulation Number 876.5130
Device Class 2


Premarket Reviews
ManufacturerDecision
ALLWIN MEDICAL DEVICES, INC
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
TELEFLEX MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
UROGEN PHARMA LTD
  SUBSTANTIALLY EQUIVALENT 1
WELL LEAD MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 1167 1167
2020 1370 1370
2021 1387 1387
2022 1280 1280
2023 1162 1162
2024 600 600

Device Problems MDRs with this Device Problem Events in those MDRs
Burst Container or Vessel 960 960
Adverse Event Without Identified Device or Use Problem 474 474
Difficult to Remove 468 468
Improper Chemical Reaction 402 402
Material Twisted/Bent 374 374
Difficult to Insert 351 351
Deflation Problem 346 346
Component Misassembled 266 266
Decrease in Pressure 254 254
Incorrect Measurement 242 242
Short Fill 217 217
Nonstandard Device 216 216
Fluid/Blood Leak 215 215
Component Missing 209 209
Product Quality Problem 182 182
Material Puncture/Hole 178 178
Partial Blockage 154 154
Material Rupture 153 153
Sharp Edges 150 150
Device Misassembled During Manufacturing /Shipping 134 134
Biocompatibility 122 122
Misassembled 119 119
Failure to Infuse 111 111
Contamination /Decontamination Problem 109 109
Break 109 109
Device Damaged Prior to Use 99 99
Leak/Splash 97 97
Material Fragmentation 96 96
Inaccurate Flow Rate 88 88
Material Split, Cut or Torn 79 79
Inadequacy of Device Shape and/or Size 78 78
Patient-Device Incompatibility 77 77
Material Too Rigid or Stiff 67 67
Patient Device Interaction Problem 65 65
Material Integrity Problem 61 61
Device Handling Problem 59 59
Tear, Rip or Hole in Device Packaging 59 59
Unsealed Device Packaging 59 59
Scratched Material 54 54
Difficult to Open or Remove Packaging Material 54 54
Defective Device 53 53
Material Deformation 51 51
Device Slipped 51 51
Material Protrusion/Extrusion 48 48
Device Contamination with Chemical or Other Material 47 47
Device Fell 46 46
Inability to Irrigate 42 42
Inflation Problem 39 39
No Flow 39 39
Therapeutic or Diagnostic Output Failure 37 37
Obstruction of Flow 37 37
Deformation Due to Compressive Stress 35 35
Detachment of Device or Device Component 34 34
Packaging Problem 34 34
Manufacturing, Packaging or Shipping Problem 34 34
Material Separation 34 34
Defective Component 33 33
Unintended Deflation 31 31
Use of Device Problem 30 30
Device Contaminated During Manufacture or Shipping 28 28
Failure to Deflate 28 28
Physical Resistance/Sticking 26 26
Failure to Align 26 26
Naturally Worn 24 24
Fracture 24 24
Device Dislodged or Dislocated 21 21
Illegible Information 21 21
Material Too Soft/Flexible 19 19
Device Markings/Labelling Problem 18 18
Incomplete or Missing Packaging 18 18
Disconnection 18 18
Inadequate Instructions for Healthcare Professional 17 17
Degraded 16 16
Calcified 16 16
Peeled/Delaminated 16 16
Shipping Damage or Problem 15 15
Material Invagination 15 15
Missing Information 14 14
Gel Leak 13 13
Complete Blockage 13 13
Restricted Flow rate 12 12
Improper or Incorrect Procedure or Method 11 11
Fitting Problem 11 11
Infusion or Flow Problem 11 11
Insufficient Information 11 11
Off-Label Use 10 10
Dent in Material 9 9
Structural Problem 9 9
Contamination 8 8
Crack 8 8
Entrapment of Device 7 7
Flaked 7 7
Inadequate or Insufficient Training 7 7
Filling Problem 6 6
Malposition of Device 6 6
Output Problem 6 6
Positioning Problem 6 6
Difficult to Open or Close 5 5
Inadequate Lubrication 5 5
Suction Failure 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3455 3455
No Consequences Or Impact To Patient 1449 1449
No Known Impact Or Consequence To Patient 1041 1041
Urinary Tract Infection 514 514
Pain 472 472
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 401 401
No Patient Involvement 315 315
Patient Problem/Medical Problem 235 235
Discomfort 183 183
Hemorrhage/Bleeding 177 177
Hematuria 94 94
Blood Loss 83 83
Foreign Body In Patient 69 69
Insufficient Information 61 61
Unspecified Infection 61 61
No Code Available 55 55
Bacterial Infection 53 53
Urinary Retention 40 40
Sepsis 25 25
Skin Inflammation/ Irritation 23 23
Tissue Breakdown 22 22
Irritation 22 22
Abrasion 21 21
Abdominal Distention 20 20
Abdominal Pain 17 17
No Information 15 16
Perforation 14 14
Laceration(s) 13 13
Bruise/Contusion 13 13
Injury 12 12
Irritability 11 11
Swelling/ Edema 11 11
Incontinence 11 11
Tissue Damage 11 11
Fistula 10 10
Fever 9 9
Swelling 9 9
Obstruction/Occlusion 9 9
Inflammation 8 8
Exposure to Body Fluids 8 8
Hematoma 7 7
Septic Shock 7 7
Skin Discoloration 7 7
Cancer 7 7
Unspecified Tissue Injury 7 7
Device Embedded In Tissue or Plaque 7 7
Unspecified Gastrointestinal Problem 6 6
Cramp(s) /Muscle Spasm(s) 6 6
Urinary Incontinence 6 6
Burning Sensation 6 6
Skin Irritation 6 6
Low Blood Pressure/ Hypotension 6 6
Abscess 6 6
Anemia 6 6
High Blood Pressure/ Hypertension 5 5
Renal Failure 5 5
Dysuria 5 5
Skin Tears 5 5
Genital Bleeding 5 5
Anxiety 4 4
Distress 3 3
Pseudoaneurysm 3 3
Rash 3 3
Internal Organ Perforation 3 3
Micturition Urgency 3 3
Dyspnea 3 3
Chest Pain 3 3
Death 2 2
Erythema 2 2
Hypersensitivity/Allergic reaction 2 2
Itching Sensation 2 2
Rupture 2 2
Urinary Frequency 2 2
Pressure Sores 2 2
Local Reaction 2 2
Pneumonia 2 2
Pneumothorax 2 2
Nausea 2 2
Fungal Infection 2 2
Respiratory Failure 2 2
Impaired Healing 2 2
Post Operative Wound Infection 2 2
Unspecified Kidney or Urinary Problem 2 2
Kidney Infection 1 1
Easy Bruising 1 1
Prolapse 1 1
Laceration(s) of Esophagus 1 1
Extubate 1 1
Skin Inflammation 1 1
Sweating 1 1
Mediastinal Shift 1 1
Joint Swelling 1 1
Malaise 1 1
Confusion/ Disorientation 1 1
Movement Disorder 1 1
Unspecified Mental, Emotional or Behavioural Problem 1 1
Respiratory Insufficiency 1 1
Paralysis 1 1
Liver Damage/Dysfunction 1 1
Muscle Spasm(s) 1 1

Recalls
Manufacturer Recall Class Date Posted
1 C.R. Bard Inc II Feb-24-2022
2 C.R. Bard, Inc. II Apr-16-2021
3 Cardinal Health 200, LLC I Feb-16-2024
4 ConvaTec, Inc II Mar-21-2019
5 Covidien Llc II May-14-2020
6 TELEFLEX LLC II Nov-11-2022
7 Teleflex Medical II Jul-26-2019
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