Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device catheter, peritoneal
Product CodeGBW
Regulation Number 878.4200
Device Class 1

MDR Year MDR Reports MDR Events
2019 1 1
2020 3 3
2021 8 8
2022 6 6
2023 28 28

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 15 15
Adverse Event Without Identified Device or Use Problem 5 5
Break 4 4
Partial Blockage 3 3
Material Split, Cut or Torn 2 2
Material Separation 2 2
Improper or Incorrect Procedure or Method 1 1
Fitting Problem 1 1
Device Damaged Prior to Use 1 1
Obstruction of Flow 1 1
Failure to Advance 1 1
Contamination of Device Ingredient or Reagent 1 1
Activation, Positioning or Separation Problem 1 1
Detachment of Device or Device Component 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Deformation 1 1
Material Protrusion/Extrusion 1 1
Material Twisted/Bent 1 1
Naturally Worn 1 1
Burst Container or Vessel 1 1
Contamination 1 1
Crack 1 1
Disconnection 1 1
Material Disintegration 1 1
Material Frayed 1 1
Material Puncture/Hole 1 1
Material Rupture 1 1
Self-Activation or Keying 1 1
Physical Resistance/Sticking 1 1
Packaging Problem 1 1
Appropriate Term/Code Not Available 1 1
Patient Device Interaction Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Peritonitis 17 17
No Clinical Signs, Symptoms or Conditions 10 10
Unspecified Infection 9 9
No Code Available 5 5
Foreign Body In Patient 3 3
Pain 3 3
Abdominal Pain 3 3
Death 3 3
Hemorrhage/Bleeding 3 3
No Consequences Or Impact To Patient 2 2
Sepsis 2 2
Tachycardia 1 1
Injury 1 1
Blood Loss 1 1
Insufficient Information 1 1
High Blood Pressure/ Hypertension 1 1
Low Blood Pressure/ Hypotension 1 1
Fever 1 1
Perforation 1 1
Myocardial Infarction 1 1

-
-