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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
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 26 26
Detachment of Device or Device Component 16 16
Difficult to Remove 14 14
Adverse Event Without Identified Device or Use Problem 11 11
Material Separation 11 11
Defective Device 11 11
Device Dislodged or Dislocated 6 6
Deformation Due to Compressive Stress 6 6
Material Deformation 5 5
Device-Device Incompatibility 5 5
Difficult to Advance 4 4
Obstruction of Flow 4 4
Entrapment of Device 4 4
Material Twisted/Bent 3 3
Device Contaminated During Manufacture or Shipping 3 3
Use of Device Problem 2 2
Unsealed Device Packaging 2 2
Material Split, Cut or Torn 2 2
Tear, Rip or Hole in Device Packaging 1 1
Difficult to Insert 1 1
Fracture 1 1
Collapse 1 1
Contamination 1 1
Device Markings/Labelling Problem 1 1
Defective Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 39 39
No Consequences Or Impact To Patient 15 15
No Known Impact Or Consequence To Patient 12 12
Hemorrhage/Bleeding 7 7
Pain 7 7
Foreign Body In Patient 6 6
Device Embedded In Tissue or Plaque 4 4
No Patient Involvement 4 4
Fever 3 3
No Code Available 2 2
Unspecified Infection 2 2
Death 2 2
Abscess 2 2
Sepsis 2 2
Inflammation 1 1
Unspecified Kidney or Urinary Problem 1 1
Urinary Tract Infection 1 1
Rash 1 1
Obstruction/Occlusion 1 1
Hemostasis 1 1
Internal Organ Perforation 1 1
Insufficient Information 1 1
Anxiety 1 1
Hematuria 1 1
Complaint, Ill-Defined 1 1
Pyrosis/Heartburn 1 1
Fistula 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation II Sep-13-2024
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