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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device tube, drainage, suprapubic
Product CodeFFA
Regulation Number 876.5090
Device Class 2

MDR Year MDR Reports MDR Events
2014 48 48
2015 78 78
2016 51 51
2017 29 29
2018 35 35
2019 26 26
2020 14 14
2021 24 24
2022 17 17
2023 12 12
2024 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Break 112 112
Difficult to Remove 33 33
Fracture 26 26
Detachment of Device or Device Component 24 24
Detachment Of Device Component 24 24
Adverse Event Without Identified Device or Use Problem 19 19
Calcified 16 16
Material Separation 13 13
Device Packaging Compromised 12 12
Entrapment of Device 12 12
Tear, Rip or Hole in Device Packaging 11 11
Defective Device 11 11
Device Dislodged or Dislocated 8 8
Device Damaged Prior to Use 8 8
Migration or Expulsion of Device 7 7
Occlusion Within Device 7 7
Deformation Due to Compressive Stress 6 6
Device-Device Incompatibility 5 5
Device Contamination with Chemical or Other Material 5 5
Material Deformation 5 5
Device Operates Differently Than Expected 4 4
Obstruction of Flow 4 4
Difficult to Advance 4 4
Unsealed Device Packaging 4 4
Leak/Splash 3 3
Device Contaminated During Manufacture or Shipping 3 3
Packaging Problem 3 3
Material Twisted/Bent 3 3
Use of Device Problem 3 3
Material Split, Cut or Torn 2 2
Partial Blockage 2 2
Torn Material 2 2
Defective Component 2 2
Component Falling 1 1
Hole In Material 1 1
Fluid/Blood Leak 1 1
Material Discolored 1 1
Material Integrity Problem 1 1
Kinked 1 1
Collapse 1 1
Insufficient Information 1 1
Peeled/Delaminated 1 1
Device Markings/Labelling Problem 1 1
Crack 1 1
Material Perforation 1 1
Air Leak 1 1
Difficult to Insert 1 1
Shelf Life Exceeded 1 1
Improper or Incorrect Procedure or Method 1 1
Device Or Device Fragments Location Unknown 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 144 144
No Patient Involvement 49 49
No Clinical Signs, Symptoms or Conditions 39 39
No Known Impact Or Consequence To Patient 30 30
Unspecified Infection 20 20
Pain 19 19
Device Embedded In Tissue or Plaque 18 18
Hemorrhage/Bleeding 12 12
Foreign Body In Patient 7 7
Abscess 5 5
Fever 5 5
Inflammation 4 4
Sepsis 4 4
Death 4 4
Obstruction/Occlusion 3 3
No Code Available 3 3
Fistula 3 3
Bowel Perforation 2 2
Hematuria 2 2
Blood Loss 2 2
Peritonitis 2 2
Pleural Effusion 2 2
Pneumothorax 2 2
Myocardial Infarction 2 2
Urinary Tract Infection 2 2
No Information 1 1
Hematoma 1 1
Multiple Organ Failure 1 1
Pyrosis/Heartburn 1 1
Nausea 1 1
Injury 1 1
Rash 1 1
Complaint, Ill-Defined 1 1
Discomfort 1 1
Insufficient Information 1 1
Hemostasis 1 1
Unspecified Kidney or Urinary Problem 1 1
Anxiety 1 1
Weight Changes 1 1
Irritability 1 1
Patient Problem/Medical Problem 1 1
Fibrosis 1 1
Internal Organ Perforation 1 1
Impaired Healing 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation II Sep-13-2024
2 Boston Scientific Corporation II May-21-2009
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