TPLC - Total Product Life Cycle

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Device	catheter, peritoneal, long-term indwelling
Product Code	FJS
Regulation Number	876.5630
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	195	195
Adverse Event Without Identified Device or Use Problem	123	123
Migration	92	92
Product Quality Problem	71	71
Malposition of Device	62	62
Obstruction of Flow	62	62
Insufficient Information	59	59
Appropriate Term/Code Not Available	58	58
Connection Problem	47	47
Material Puncture/Hole	42	42
Infusion or Flow Problem	40	40
Migration or Expulsion of Device	40	40
Insufficient Flow or Under Infusion	36	36
Improper or Incorrect Procedure or Method	34	34
Fluid/Blood Leak	32	32
Detachment of Device or Device Component	27	27
Positioning Problem	25	25
Complete Blockage	21	21
Improper Flow or Infusion	18	18
Leak/Splash	16	16
Defective Component	12	12
Microbial Contamination of Device	12	12
Therapeutic or Diagnostic Output Failure	10	10
Material Split, Cut or Torn	9	9
Contamination	9	9
Fracture	8	8
Material Twisted/Bent	8	8
Crack	7	7
Defective Device	7	7
No Flow	6	6
Material Integrity Problem	6	6
Output Problem	6	6
Material Separation	5	5
Material Deformation	5	5
Protective Measures Problem	5	5
Suction Problem	5	5
Contamination /Decontamination Problem	5	5
Material Frayed	5	5
Difficult to Remove	4	4
Failure to Clean Adequately	4	4
Use of Device Problem	4	4
Component Missing	4	4
Material Perforation	4	4
Entrapment of Device	4	4
Partial Blockage	4	4
Inadequate Ultra Filtration	3	3
Patient Device Interaction Problem	3	3
Material Fragmentation	3	3
Unintended Movement	3	3
Device Contamination with Chemical or Other Material	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Insufficient Information	282	282
No Clinical Signs, Symptoms or Conditions	270	270
Peritonitis	194	194
Unspecified Infection	114	114
Abdominal Pain	61	61
Bacterial Infection	57	57
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	50	50
Pain	38	38
No Consequences Or Impact To Patient	37	37
Unintended Radiation Exposure	25	25
No Information	25	25
Foreign Body In Patient	18	18
Failure of Implant	16	16
Fungal Infection	14	14
Swelling/ Edema	14	14
Hemorrhage/Bleeding	14	14
Fever	13	13
Thrombosis/Thrombus	12	12
Sepsis	10	10
Erythema	9	9
No Code Available	8	8
Death	8	8
Hypervolemia	8	8
Vomiting	8	8
Device Embedded In Tissue or Plaque	8	8
Constipation	7	7
Adhesion(s)	7	7
Thrombosis	7	7
Dyspnea	6	6
Discomfort	6	6
Hernia	6	6
Nausea	5	5
Inflammation	5	5
Hematoma	5	5
No Known Impact Or Consequence To Patient	5	5
Chest Pain	4	4
Obstruction/Occlusion	4	4
Injury	4	4
Cardiac Arrest	4	4
Abscess	3	3
Cough	3	3
Hemothorax	3	3
Bradycardia	3	3
Swelling	3	3
Chills	3	3
Pulmonary Embolism	3	3
Hypersensitivity/Allergic reaction	3	3
Radiation Exposure, Unintended	3	3
Itching Sensation	3	3
Purulent Discharge	3	3

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