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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, peritoneal
Regulation Description Introduction/drainage catheter and accessories.
Product CodeGBW
Regulation Number 878.4200
Device Class 1

MDR Year MDR Reports MDR Events
2021 8 8
2022 6 10
2023 28 28
2026 6 6

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
Partial Blockage 3 3
Material Separation 2 2
Material Split, Cut or Torn 2 2
Material Rupture 1 1
Contamination 1 1
Improper or Incorrect Procedure or Method 1 1
Naturally Worn 1 1
Material Twisted/Bent 1 1
Break 1 1
Material Protrusion/Extrusion 1 1
Crack 1 1
Mechanical Jam 1 1
Appropriate Device Problem Term/Code Not Available 1 1
Burst Container or Vessel 1 1
Material Deformation 1 1
Material Puncture/Hole 1 1
Obstruction of Flow 1 1
Self-Activation or Keying 1 1
Detachment of Device or Device Component 1 1
Contamination of Device Ingredient or Reagent 1 1
Disconnection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Peritonitis 18 18
Unspecified Infection 10 10
No Clinical Signs, Symptoms or Conditions 8 12
No Code Available 5 5
Insufficient Information 4 4
Abdominal Pain 4 4
Hemorrhage/Blood Loss/Bleeding 3 3
Death 3 3
Pain 3 3
Foreign Body In Patient 3 3
Failure of Implant 2 2
Sepsis 2 2
Low Blood Pressure/ Hypotension 1 1
Laceration(s) 1 1
Fever 1 1
No Consequences Or Impact To Patient 1 1
Myocardial Infarction 1 1
Tachycardia 1 1
High Blood Pressure/ Hypertension 1 1
Perforation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 ARROW INTERNATIONAL, LLC I Jun-13-2026
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