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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, urological (antimicrobial) and accessories
Product CodeMJC
Regulation Number 876.5130
Device Class 2

MDR Year MDR Reports MDR Events
2019 1270 1270
2020 1433 1433
2021 1464 1464
2022 1796 1796
2023 1991 1991
2024 358 358

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 1502 1502
Decrease in Pressure 1238 1238
Material Puncture/Hole 1115 1115
Difficult to Remove 1051 1051
Failure to Infuse 1025 1025
Deflation Problem 997 997
Burst Container or Vessel 789 789
Inflation Problem 289 289
Material Split, Cut or Torn 286 286
Material Fragmentation 254 254
Leak/Splash 244 244
Break 219 219
Inaccurate Flow Rate 194 194
Device Fell 187 187
Material Twisted/Bent 154 154
Short Fill 151 151
Device Slipped 132 132
Erratic or Intermittent Display 126 126
Component Misassembled 119 119
Component Missing 109 109
Partial Blockage 104 104
Fracture 102 102
Device Contamination with Chemical or Other Material 100 100
Material Rupture 94 94
Material Invagination 90 90
Device Dislodged or Dislocated 79 79
Gel Leak 72 72
Dent in Material 66 66
Disconnection 63 63
No Flow 60 60
Material Protrusion/Extrusion 53 53
Deformation Due to Compressive Stress 53 53
Physical Resistance/Sticking 52 52
Tear, Rip or Hole in Device Packaging 49 49
Restricted Flow rate 48 48
Device Handling Problem 47 47
Defective Component 39 39
Material Deformation 36 36
Difficult to Insert 35 35
Device Damaged Prior to Use 34 34
Adverse Event Without Identified Device or Use Problem 33 33
Crack 33 33
Misassembled 32 32
Obstruction of Flow 32 32
Incorrect Measurement 29 29
Fitting Problem 28 28
Material Discolored 27 27
Inadequate Instructions for Healthcare Professional 25 25
Nonstandard Device 25 25
Detachment of Device or Device Component 23 23
Product Quality Problem 19 19
Packaging Problem 18 18
Scratched Material 16 16
Temperature Problem 16 16
Illegible Information 16 16
Contamination /Decontamination Problem 16 16
Use of Device Problem 16 16
Defective Device 15 15
Manufacturing, Packaging or Shipping Problem 15 15
Patient-Device Incompatibility 14 14
Device Markings/Labelling Problem 14 14
Biocompatibility 13 13
Therapeutic or Diagnostic Output Failure 13 13
Incorrect, Inadequate or Imprecise Result or Readings 13 13
Filling Problem 13 13
Material Integrity Problem 12 12
Patient Device Interaction Problem 11 11
Infusion or Flow Problem 9 9
Calcified 8 8
Inadequacy of Device Shape and/or Size 8 8
Unsealed Device Packaging 7 7
Insufficient Flow or Under Infusion 7 7
Improper or Incorrect Procedure or Method 6 6
Device Sensing Problem 6 6
Device Contaminated During Manufacture or Shipping 6 6
No Apparent Adverse Event 6 6
Insufficient Information 6 6
Unclear Information 6 6
Material Separation 6 6
Inability to Irrigate 6 6
Complete Blockage 6 6
No Display/Image 6 6
Contamination 5 5
Entrapment of Device 5 5
Sharp Edges 5 5
Unintended Deflation 4 4
Missing Information 4 4
Output Problem 4 4
Moisture or Humidity Problem 4 4
Gas/Air Leak 4 4
Improper Chemical Reaction 4 4
Improper Flow or Infusion 4 4
Device Displays Incorrect Message 4 4
Melted 4 4
Shipping Damage or Problem 4 4
Off-Label Use 4 4
Material Too Rigid or Stiff 4 4
Unable to Obtain Readings 3 3
Flaked 3 3
Collapse 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5581 5581
No Known Impact Or Consequence To Patient 1837 1837
No Consequences Or Impact To Patient 1686 1686
No Patient Involvement 872 873
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 207 207
Patient Problem/Medical Problem 122 122
Foreign Body In Patient 91 91
Insufficient Information 75 75
Pain 59 59
No Code Available 53 53
Discomfort 36 36
Urinary Tract Infection 32 32
Hematuria 29 29
No Information 16 16
Urinary Retention 15 15
Tissue Breakdown 14 14
Device Embedded In Tissue or Plaque 14 14
Hemorrhage/Bleeding 13 13
Unspecified Infection 9 9
Injury 6 6
Abdominal Distention 6 6
Cancer 5 5
Death 5 5
Perforation 4 4
Fistula 3 3
Hematoma 3 3
Swelling 3 3
Tissue Damage 3 3
Failure of Implant 3 3
Blood Loss 3 3
Swelling/ Edema 2 2
Incontinence 2 2
Sepsis 2 2
Burning Sensation 2 2
Distress 2 2
Complaint, Ill-Defined 1 1
Reaction 1 1
Irritability 1 1
Premature Labor 1 1
Confusion/ Disorientation 1 1
Chills 1 1
Skin Irritation 1 1
High Blood Pressure/ Hypertension 1 1
Hypothermia 1 1
Abdominal Pain 1 1
Exposure to Body Fluids 1 1
Erosion 1 1
Bradycardia 1 1
Bruise/Contusion 1 1
Calcium Deposits/Calcification 1 1
Chest Pain 1 1
Pneumonia 1 1
Rash 1 1
Respiratory Distress 1 1
Inflammation 1 1
Irritation 1 1
Muscle Spasm(s) 1 1
Internal Organ Perforation 1 1
Unspecified Gastrointestinal Problem 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Skin Inflammation/ Irritation 1 1
Unspecified Tissue Injury 1 1
Alteration In Body Temperature 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Bard Medical Division II Feb-06-2019
2 Bard Medical Division II Feb-05-2019
3 C.R. Bard Inc II Sep-23-2021
4 C.R. Bard Inc II May-13-2020
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