TPLC - Total Product Life Cycle

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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	227	227
Adverse Event Without Identified Device or Use Problem	139	139
Migration	107	107
Malposition of Device	62	62
Obstruction of Flow	61	61
Insufficient Information	61	61
Appropriate Term/Code Not Available	58	58
Product Quality Problem	58	58
Connection Problem	47	47
Insufficient Flow or Under Infusion	45	45
Material Puncture/Hole	43	43
Infusion or Flow Problem	38	38
Improper or Incorrect Procedure or Method	35	35
Detachment of Device or Device Component	32	32
Migration or Expulsion of Device	30	30
Fluid/Blood Leak	26	26
Positioning Problem	25	25
Complete Blockage	21	21
Leak/Splash	18	18
Improper Flow or Infusion	18	18
Fracture	12	12
Defective Component	12	12
Microbial Contamination of Device	11	11
Therapeutic or Diagnostic Output Failure	10	10
Material Split, Cut or Torn	9	9
Contamination	9	9
Output Problem	8	8
Crack	7	7
Defective Device	7	11
Material Deformation	7	7
Material Twisted/Bent	7	7
No Flow	6	6
Material Separation	6	6
Use of Device Problem	6	6
Material Frayed	5	5
Suction Problem	5	5
Protective Measures Problem	5	5
Material Integrity Problem	5	5
Contamination /Decontamination Problem	5	5
Patient Device Interaction Problem	5	5
Partial Blockage	4	4
Failure to Clean Adequately	4	4
Difficult to Remove	4	4
Entrapment of Device	4	4
Component Missing	4	4
Disconnection	3	3
Device Contamination with Chemical or Other Material	3	3
Material Perforation	3	3
Material Fragmentation	3	3
Inadequate Ultra Filtration	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Insufficient Information	331	335
No Clinical Signs, Symptoms or Conditions	299	299
Peritonitis	190	190
Unspecified Infection	109	109
Abdominal Pain	63	63
Bacterial Infection	58	58
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	53	53
Pain	41	41
Unintended Radiation Exposure	27	27
Foreign Body In Patient	20	20
No Consequences Or Impact To Patient	20	20
No Information	19	19
Fungal Infection	16	16
Failure of Implant	16	16
Fever	14	14
Hemorrhage/Bleeding	14	14
Thrombosis/Thrombus	13	13
Swelling/ Edema	13	13
Sepsis	10	10
Erythema	9	9
Discomfort	8	8
Device Embedded In Tissue or Plaque	8	8
Hypervolemia	8	8
Constipation	7	7
Hernia	7	7
Vomiting	7	7
Death	6	6
Adhesion(s)	6	6
Dyspnea	6	6
Nausea	5	5
Chills	5	5
Cardiac Arrest	5	5
No Code Available	4	4
Inflammation	4	4
Hematoma	4	4
Chest Pain	4	4
Obstruction/Occlusion	4	4
Abscess	4	4
Pulmonary Embolism	3	3
Thrombosis	3	3
Injury	3	3
No Known Impact Or Consequence To Patient	3	3
Bradycardia	3	3
Itching Sensation	3	3
Purulent Discharge	3	3
Perforation of Vessels	3	3
Cough	3	3
Abdominal Distention	3	3
Stroke/CVA	3	3
Hypersensitivity/Allergic reaction	3	3

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