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	212	212
Adverse Event Without Identified Device or Use Problem	133	133
Migration	108	108
Malposition of Device	62	62
Obstruction of Flow	62	62
Insufficient Information	61	61
Appropriate Term/Code Not Available	58	58
Product Quality Problem	57	57
Connection Problem	47	47
Material Puncture/Hole	41	41
Insufficient Flow or Under Infusion	40	40
Infusion or Flow Problem	37	37
Improper or Incorrect Procedure or Method	34	34
Migration or Expulsion of Device	30	30
Detachment of Device or Device Component	28	28
Fluid/Blood Leak	25	25
Positioning Problem	25	25
Complete Blockage	21	21
Improper Flow or Infusion	18	18
Leak/Splash	17	17
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
Fracture	8	8
Crack	7	7
Defective Device	7	7
Material Twisted/Bent	7	7
No Flow	6	6
Material Deformation	6	6
Output Problem	6	6
Material Frayed	5	5
Suction Problem	5	5
Protective Measures Problem	5	5
Contamination /Decontamination Problem	5	5
Material Separation	4	4
Partial Blockage	4	4
Failure to Clean Adequately	4	4
Difficult to Remove	4	4
Entrapment of Device	4	4
Patient Device Interaction Problem	4	4
Component Missing	4	4
Use of Device Problem	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
Material Integrity Problem	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Insufficient Information	326	326
No Clinical Signs, Symptoms or Conditions	286	286
Peritonitis	186	186
Unspecified Infection	105	105
Abdominal Pain	61	61
Bacterial Infection	58	58
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	52	52
Pain	37	37
Unintended Radiation Exposure	25	25
No Consequences Or Impact To Patient	20	20
No Information	19	19
Foreign Body In Patient	17	17
Failure of Implant	16	16
Fungal Infection	15	15
Thrombosis/Thrombus	14	14
Swelling/ Edema	14	14
Hemorrhage/Bleeding	14	14
Fever	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
Adhesion(s)	6	6
Dyspnea	6	6
Death	6	6
Nausea	5	5
No Code Available	4	4
Inflammation	4	4
Hematoma	4	4
Chills	4	4
Chest Pain	4	4
Cardiac Arrest	4	4
Obstruction/Occlusion	4	4
Pulmonary Embolism	3	3
Thrombosis	3	3
Injury	3	3
No Known Impact Or Consequence To Patient	3	3
Bradycardia	3	3
Abscess	3	3
Itching Sensation	3	3
Purulent Discharge	3	3
Perforation of Vessels	3	3
Stroke/CVA	3	3
Cough	3	3
Abdominal Distention	3	3
Hypersensitivity/Allergic reaction	3	3

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