TPLC - Total Product Life Cycle

• Device: catheter, straight
• Product Code: EZD
• Regulation Number: 876.5130
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
BIG BLUE BIOTECH, INC.
	SUBSTANTIALLY EQUIVALENT	1
BONREE MEDICAL CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
CHENGDU DAXAN INNOVATIVE MEDICAL TECH. CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
COLOPLAST
	SUBSTANTIALLY EQUIVALENT	5
COLOPLAST CORP
	SUBSTANTIALLY EQUIVALENT	1
CONVATEC
	SUBSTANTIALLY EQUIVALENT	1
1.  K221593  Cure Ultra Male, Cure Ultra Female, Cure Ultra Plu ...
CONVATEC, INC.
	SUBSTANTIALLY EQUIVALENT	1
	SUBSTANTIALLY EQUIVALENT - KIT	1
1.  K221593  Cure Ultra Male, Cure Ultra Female, Cure Ultra Plu ...
DENTSPLY SIRONA
	SUBSTANTIALLY EQUIVALENT	2
HANGZHOU JIMUSHI MEDITECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HOLLISTER INCORPORATED
	SUBSTANTIALLY EQUIVALENT	3
WELL LEAD MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2019	466	466
2020	563	563
2021	994	994
2022	486	486
2023	555	555
2024	31	31

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	597	597
Defective Device	574	574
Improper Chemical Reaction	340	340
Product Quality Problem	270	270
Difficult to Insert	226	226
Sharp Edges	180	180
Biocompatibility	151	151
Difficult to Remove	148	148
Incorrect Measurement	130	130
Component Misassembled	102	102
Patient-Device Incompatibility	96	96
Material Twisted/Bent	93	93
Inadequacy of Device Shape and/or Size	62	62
Component Missing	62	62
Material Integrity Problem	55	55
Material Fragmentation	51	51
Inaccurate Flow Rate	49	49
Misassembled	44	44
Device Damaged Prior to Use	44	44
Difficult to Open or Close	42	42
Nonstandard Device	36	36
Unsealed Device Packaging	35	35
Contamination /Decontamination Problem	31	31
Insufficient Information	30	30
Manufacturing, Packaging or Shipping Problem	29	29
Therapeutic or Diagnostic Output Failure	28	28
Device Handling Problem	28	28
Delivered as Unsterile Product	26	26
Material Deformation	24	24
Material Protrusion/Extrusion	21	21
Scratched Material	21	21
Fluid/Blood Leak	21	21
Defective Component	17	17
Patient Device Interaction Problem	17	17
No Flow	15	15
Use of Device Problem	13	13
Structural Problem	12	12
Obstruction of Flow	11	11
Leak/Splash	11	11
Material Too Soft/Flexible	10	10
Appropriate Term/Code Not Available	9	9
Physical Resistance/Sticking	9	9
Partial Blockage	9	9
Break	9	9
Short Fill	9	9
Tear, Rip or Hole in Device Packaging	8	8
Improper or Incorrect Procedure or Method	8	8
Material Too Rigid or Stiff	8	8
Inadequate Instructions for Healthcare Professional	8	8
Device Misassembled During Manufacturing /Shipping	7	7
Material Split, Cut or Torn	7	7
Difficult to Open or Remove Packaging Material	6	6
Device Markings/Labelling Problem	6	6
Incomplete or Missing Packaging	5	5
Off-Label Use	5	5
Infusion or Flow Problem	5	5
Illegible Information	4	4
Inadequate Lubrication	4	4
Shipping Damage or Problem	4	4
Detachment of Device or Device Component	4	4
Device Ingredient or Reagent Problem	4	4
Deformation Due to Compressive Stress	3	3
Fracture	3	3
Contamination	3	3
Disconnection	3	3
Labelling, Instructions for Use or Training Problem	3	3
Missing Information	3	3
No Apparent Adverse Event	3	3
Output Problem	3	3
Device Contamination with Chemical or Other Material	3	3
Improper Flow or Infusion	2	2
Flaked	2	2
Restricted Flow rate	2	2
Deflation Problem	2	2
Material Separation	2	2
Dull, Blunt	2	2
Insufficient Flow or Under Infusion	2	2
Device Slipped	2	2
Inadequate or Insufficient Training	1	1
Unstable	1	1
Fitting Problem	1	1
Material Perforation	1	1
Device Sensing Problem	1	1
Contamination of Device Ingredient or Reagent	1	1
Blocked Connection	1	1
Failure to Advance	1	1
Device Displays Incorrect Message	1	1
Malposition of Device	1	1
Material Puncture/Hole	1	1
Material Rupture	1	1
Migration or Expulsion of Device	1	1
Moisture Damage	1	1
Positioning Failure	1	1
Crack	1	1
Complete Blockage	1	1
Collapse	1	1
Flushing Problem	1	1
Gel Leak	1	1
Packaging Problem	1	1
Protective Measures Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1323	1323
Urinary Tract Infection	742	742
No Consequences Or Impact To Patient	489	489
No Known Impact Or Consequence To Patient	393	393
Pain	180	180
Hemorrhage/Bleeding	128	128
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	122	122
Patient Problem/Medical Problem	105	105
Discomfort	87	87
Unspecified Infection	74	74
No Patient Involvement	68	68
Abrasion	32	32
Sepsis	25	25
No Code Available	24	24
Hematuria	20	20
Blood Loss	20	20
Irritation	15	15
Burning Sensation	14	14
Unspecified Tissue Injury	14	14
Injury	10	10
Tissue Breakdown	10	10
Laceration(s)	9	9
Insufficient Information	8	8
Irritability	7	7
Tissue Damage	6	6
Urinary Retention	6	6
Skin Irritation	6	6
Bacterial Infection	6	6
Fever	6	6
Hypersensitivity/Allergic reaction	5	5
Skin Tears	5	5
No Information	5	5
Nausea	4	4
Rash	4	4
Bruise/Contusion	3	3
Vomiting	3	3
Fungal Infection	3	3
Confusion/ Disorientation	3	3
Headache	3	3
Thrombus	3	3
Genital Bleeding	3	3
Skin Inflammation/ Irritation	3	3
Hypernatremia	2	2
Abdominal Cramps	2	2
Dysuria	2	2
Foreign Body In Patient	2	2
Death	2	2
Hyperglycemia	2	2
Local Reaction	2	2
Swelling	2	2
Pneumonia	2	2
Septic Shock	1	1
Tachycardia	1	1
Thrombosis	1	1
Renal Failure	1	1
Scar Tissue	1	1
Scarring	1	1
Internal Organ Perforation	1	1
Foreign Body Sensation in Eye	1	1
Low Blood Pressure/ Hypotension	1	1
Inflammation	1	1
Dehydration	1	1
Diarrhea	1	1
Erythema	1	1
Cyst(s)	1	1
Anemia	1	1
Aspiration/Inhalation	1	1
Cancer	1	1
Dementia	1	1
Syncope/Fainting	1	1
Kidney Infection	1	1
Unspecified Kidney or Urinary Problem	1	1
Urinary Frequency	1	1
Rupture	1	1
Malaise	1	1
Reaction	1	1
Chills	1	1
Cramp(s)	1	1
Perforation of Vessels	1	1
Urinary Incontinence	1	1
Swelling/ Edema	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	C.R. Bard Inc	II	Jun-08-2023
2	Wellspect HealthCare (Division of DENTSPLY IH AB)	II	Jul-17-2020