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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device peritoneal, drainage catheter for refractory ascites, long-term indwelling
Regulation Description Peritoneal dialysis system and accessories.
Definition For drainage of refractory ascites with long-term occurrence from the peritoneal cavity.
Product CodePNG
Regulation Number 876.5630
Device Class 2


Premarket Reviews
ManufacturerDecision
BARD PERIPHERAL VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
BEARPAC MEDICAL
  SUBSTANTIALLY EQUIVALENT - KIT 1
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT - KIT 1
PFM MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT - KIT 1
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 15 16
2022 18 18
2023 21 21
2024 18 19
2025 31 31
2026 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Break 21 22
Adverse Event Without Identified Device or Use Problem 17 17
Leak/Splash 11 11
Wrong Label 11 11
Fluid/Blood Leak 8 8
Detachment of Device or Device Component 5 5
Crack 4 4
Device Markings/Labelling Problem 4 4
Complete Blockage 4 4
Defective Device 4 5
Contamination 4 4
Delivered as Unsterile Product 4 5
Fracture 3 3
Disconnection 2 3
Material Split, Cut or Torn 2 2
Material Puncture/Hole 2 2
Device Handling Problem 2 2
Product Quality Problem 2 2
Device Appears to Trigger Rejection 2 2
Fitting Problem 1 1
Insufficient Information 1 1
Defective Component 1 1
Patient Device Interaction Problem 1 1
Component Missing 1 2
Obstruction of Flow 1 1
Material Twisted/Bent 1 1
Tear, Rip or Hole in Device Packaging 1 1
Migration 1 1
Nonstandard Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 74 76
Insufficient Information 15 15
Peritonitis 4 4
Unspecified Infection 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Obstruction/Occlusion 3 3
Foreign Body In Patient 3 3
Hematoma 2 2
Implant Pain 2 2
Electrolyte Imbalance 2 2
Bacterial Infection 2 2
Pneumothorax 1 1
Sepsis 1 1
Vascular Dissection 1 1
Skin Inflammation/ Irritation 1 1
Adhesion(s) 1 1
Inflammation 1 1
Itching Sensation 1 1
Rash 1 1
Discomfort 1 1
Laceration(s) 1 1
Renal Impairment 1 1
Pulmonary Edema 1 1
Swelling/ Edema 1 1
Hemorrhage/Bleeding 1 1
Ascites 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Merit Medical Systems, Inc. II Jun-14-2023
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