TPLC - Total Product Life Cycle

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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

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