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TPLC
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Device
peritoneal, drainage catheter for refractory ascites, long-term indwelling
Definition
For drainage of refractory ascites with long-term occurrence from the peritoneal cavity.
Product Code
PNG
Regulation Number
876.5630
Device Class
2
Premarket Reviews
Manufacturer
Decision
BEARPAC MEDICAL
SUBSTANTIALLY EQUIVALENT - KIT
1
C.R. BARD, INC.
SUBSTANTIALLY EQUIVALENT
1
CAREFUSION
SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS
1
SUBSTANTIALLY EQUIVALENT - KIT
3
MERIT MEDICAL SYSTEMS, INC.
SUBSTANTIALLY EQUIVALENT - KIT
1
PFM MEDICAL, INC
SUBSTANTIALLY EQUIVALENT - KIT
1
PFM MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT - KIT
1
ROCKET MEDICAL PLC
SUBSTANTIALLY EQUIVALENT - KIT
1
SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS
1
MDR Year
MDR Reports
MDR Events
2017
3
3
2018
6
6
2019
9
9
2020
15
15
2021
15
15
2022
18
18
2023
21
21
2024
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Leak/Splash
14
14
Adverse Event Without Identified Device or Use Problem
14
14
Break
9
9
Defective Device
7
7
Detachment of Device or Device Component
6
6
Fluid/Blood Leak
5
5
Fracture
4
4
Contamination
4
4
Material Separation
4
4
Delivered as Unsterile Product
3
3
Disconnection
3
3
Material Split, Cut or Torn
3
3
Obstruction of Flow
2
2
Device Markings/Labelling Problem
2
2
Crack
2
2
Complete Blockage
2
2
Product Quality Problem
2
2
Device Appears to Trigger Rejection
1
1
Material Puncture/Hole
1
1
Tidal Volume Fluctuations
1
1
Insufficient Flow or Under Infusion
1
1
Defective Component
1
1
Component Missing
1
1
Tear, Rip or Hole in Device Packaging
1
1
Restricted Flow rate
1
1
Device Dislodged or Dislocated
1
1
Improper Device Output
1
1
Improper Flow or Infusion
1
1
Material Twisted/Bent
1
1
No Flow
1
1
No Pressure
1
1
Insufficient Information
1
1
Device Handling Problem
1
1
Patient Device Interaction Problem
1
1
Migration
1
1
Suction Failure
1
1
Malposition of Device
1
1
Patient-Device Incompatibility
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
34
34
No Consequences Or Impact To Patient
14
14
Insufficient Information
8
8
No Known Impact Or Consequence To Patient
5
5
Peritonitis
4
4
Discomfort
3
3
Obstruction/Occlusion
3
3
Foreign Body In Patient
3
3
Dyspnea
3
3
Hematoma
2
2
Electrolyte Imbalance
2
2
Pneumothorax
2
2
Bacterial Infection
2
2
Failure of Implant
2
2
Unspecified Infection
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
No Code Available
2
2
Renal Impairment
1
1
Implant Pain
1
1
Vascular Dissection
1
1
Radiation Exposure, Unintended
1
1
Ascites
1
1
Abdominal Distention
1
1
Inflammation
1
1
Laceration(s)
1
1
Pain
1
1
Calcium Deposits/Calcification
1
1
Cellulitis
1
1
Death
1
1
Pulmonary Edema
1
1
Rash
1
1
Sepsis
1
1
Adhesion(s)
1
1
Hemorrhage/Bleeding
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Merit Medical Systems, Inc.
II
Jun-14-2023
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