TPLC - Total Product Life Cycle

show TPLC since

Device	catheter, peritoneal, long-term indwelling
Regulation Description	Peritoneal dialysis system and accessories.
Product Code	FJS
Regulation Number	876.5630
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	192	192
Adverse Event Without Identified Device or Use Problem	134	134
Migration	108	108
Malposition of Device	60	60
Insufficient Device Problem Information	60	60
Appropriate Device Problem Term/Code Not Available	58	58
Obstruction of Flow	56	56
Connection Problem	47	47
Insufficient Flow or Under Infusion	45	45
Material Puncture/Hole	40	40
Improper or Incorrect Procedure or Method	33	33
Detachment of Device or Device Component	32	32
Product Quality Problem	27	27
Positioning Problem	25	25
Infusion or Flow Problem	23	23
Fluid/Blood Leak	22	22
Complete Blockage	21	21
Migration or Expulsion of Device	20	20
Leak/Splash	17	17
Improper Flow or Infusion	16	16
Therapeutic or Diagnostic Output Failure	12	12
Microbial Contamination of Device	11	11
Defective Component	11	11
Contamination	9	9
Material Split, Cut or Torn	9	9
Output Problem	8	8
Fracture	7	7
Crack	7	7
Material Deformation	7	7
Material Twisted/Bent	6	6
No Flow	5	5
Suction Problem	5	5
Contamination /Decontamination Problem	5	5
Material Frayed	5	5
Defective Device	5	5
Material Integrity Problem	5	5
Protective Measures Problem	5	5
Component Missing	4	4
Use of Device Problem	4	4
Failure to Clean Adequately	4	4
Difficult to Remove	4	4
Entrapment of Device	4	4
Partial Blockage	4	4
Material Separation	3	3
Device Contamination with Chemical or Other Material	3	3
Unintended Movement	3	3
Material Perforation	3	3
Inadequate Ultra Filtration	3	3
Patient Device Interaction Problem	3	3
Disconnection	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Insufficient Information	360	364
No Clinical Signs, Symptoms or Conditions	303	303
Peritonitis	244	244
Unspecified Infection	126	126
Abdominal Pain	106	106
Bacterial Infection	69	69
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	61	61
Pain	48	48
Failure of Implant	27	27
Fungal Infection	23	23
Unintended Radiation Exposure	22	22
Foreign Body In Patient	19	19
Hemorrhage/Blood Loss/Bleeding	18	18
Swelling/ Edema	18	18
Hypervolemia	16	16
Erythema	14	14
Thrombosis/Thrombus	13	13
Fever	13	13
Sepsis	12	12
Constipation	12	12
Dyspnea	11	11
Medical device site infection	10	10
Discomfort	9	9
Hernia	9	9
Device Embedded In Tissue or Plaque	9	9
Adhesion(s)	8	8
Vomiting	8	8
Inflammation	7	7
Cardiac Arrest	7	7
Peritoneal effluent abnormal	7	7
Nausea	7	7
Chills	7	7
High White Blood Cell Count	6	6
Abscess	6	6
Obstruction/Occlusion	6	6
Bacteremia	5	5
Chest Pain	5	5
Purulent Discharge	5	5
Confusion/ Disorientation	4	4
Hematoma	4	4
Abdominal Distention	4	4
Low Blood Pressure/ Hypotension	4	4
Diarrhea	4	4
Perforation of Vessels	3	3
Urinary Tract Infection	3	3
Bowel Perforation	3	3
High Blood Pressure/ Hypertension	3	3
Muscle Weakness/Atrophy	3	3
Hypersensitivity/Allergic reaction	3	3
Urinary Retention	3	3

Recalls
Manufacturer		Recall Class	Date Posted
1	Merit Medical Systems, Inc.	II	Apr-07-2023