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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
11
11
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
15
15
Adverse Event Without Identified Device or Use Problem
15
15
Leak/Splash
14
14
Defective Device
7
7
Fluid/Blood Leak
7
7
Detachment of Device or Device Component
6
6
Delivered as Unsterile Product
4
4
Fracture
4
4
Contamination
4
4
Material Separation
4
4
Material Split, Cut or Torn
3
3
Disconnection
3
3
Crack
2
2
Device Markings/Labelling Problem
2
2
Complete Blockage
2
2
Obstruction of Flow
2
2
Product Quality Problem
2
2
Improper Device Output
1
1
Malposition of Device
1
1
Restricted Flow rate
1
1
Suction Failure
1
1
Patient-Device Incompatibility
1
1
Insufficient Information
1
1
Material Puncture/Hole
1
1
Tidal Volume Fluctuations
1
1
Defective Component
1
1
No Pressure
1
1
Insufficient Flow or Under Infusion
1
1
Device Handling Problem
1
1
Device Dislodged or Dislocated
1
1
Patient Device Interaction Problem
1
1
Improper Flow or Infusion
1
1
Component Missing
1
1
Material Twisted/Bent
1
1
Migration
1
1
Tear, Rip or Hole in Device Packaging
1
1
Device Appears to Trigger Rejection
1
1
No Flow
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
44
44
No Consequences Or Impact To Patient
14
14
Insufficient Information
8
8
No Known Impact Or Consequence To Patient
5
5
Peritonitis
4
4
Obstruction/Occlusion
3
3
Foreign Body In Patient
3
3
Discomfort
3
3
Dyspnea
3
3
Unspecified Infection
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Pneumothorax
2
2
Failure of Implant
2
2
No Code Available
2
2
Hematoma
2
2
Electrolyte Imbalance
2
2
Bacterial Infection
2
2
Death
1
1
Radiation Exposure, Unintended
1
1
Sepsis
1
1
Vascular Dissection
1
1
Abdominal Distention
1
1
Implant Pain
1
1
Adhesion(s)
1
1
Inflammation
1
1
Cellulitis
1
1
Rash
1
1
Pain
1
1
Laceration(s)
1
1
Renal Impairment
1
1
Calcium Deposits/Calcification
1
1
Pulmonary 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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