TPLC - Total Product Life Cycle

• Device: catheter, coude
• Product Code: EZC
• Regulation Number: 876.5130
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
TELEFLEX MEDICAL
	SUBSTANTIALLY EQUIVALENT	2

MDR Year	MDR Reports	MDR Events
2014	14	14
2015	20	20
2016	170	170
2017	963	963
2018	886	886
2019	1000	1000
2020	1027	1027
2021	1030	1030
2022	1365	1365
2023	1155	1155
2024	200	200

Device Problems	MDRs with this Device Problem	Events in those MDRs
Deflation Problem	1119	1119
Burst Container or Vessel	962	962
Fluid/Blood Leak	848	848
Difficult to Remove	683	683
Decrease in Pressure	486	486
Failure to Infuse	448	448
Material Puncture/Hole	408	408
Partial Blockage	365	365
Break	336	336
Inflation Problem	336	336
Leak/Splash	317	317
Inaccurate Flow Rate	289	289
Material Rupture	234	234
Device Dislodged or Dislocated	218	218
Adverse Event Without Identified Device or Use Problem	199	199
Material Fragmentation	197	197
Erratic or Intermittent Display	157	157
Device Fell	154	154
No Flow	142	142
Component Falling	126	126
Component Missing	125	125
Material Split, Cut or Torn	125	125
Device Operates Differently Than Expected	106	106
Patient Device Interaction Problem	93	93
Device Slipped	78	78
Device Sensing Problem	76	76
Obstruction of Flow	75	75
Biocompatibility	74	74
Material Deformation	67	67
Component Misassembled	65	65
Detachment of Device or Device Component	65	65
Incorrect Measurement	63	63
Disconnection	62	62
Material Invagination	57	57
Illegible Information	56	56
Patient-Device Incompatibility	55	55
Inadequate or Insufficient Training	55	55
Difficult to Insert	53	53
Hole In Material	52	52
Device Contamination with Chemical or Other Material	52	52
Complete Blockage	51	51
Detachment Of Device Component	50	50
Calcified	49	49
Material Twisted/Bent	40	40
Inadequate Instructions for Healthcare Professional	38	38
Misassembled	38	38
Tear, Rip or Hole in Device Packaging	38	38
Use of Device Problem	38	38
Deformation Due to Compressive Stress	37	37
Dent in Material	36	36
Device Damaged Prior to Use	34	34
Short Fill	34	34
Insufficient Information	32	32
Device Handling Problem	32	32
Physical Resistance/Sticking	30	30
Gel Leak	30	30
Restricted Flow rate	30	30
Missing Information	29	29
Nonstandard Device	28	28
Fracture	27	27
Inability to Irrigate	27	27
Improper or Incorrect Procedure or Method	27	27
Material Integrity Problem	27	27
Defective Component	26	26
No Display/Image	24	24
Inadequacy of Device Shape and/or Size	23	23
Defective Device	23	23
Naturally Worn	22	22
Infusion or Flow Problem	19	19
Material Protrusion/Extrusion	18	18
Crack	18	18
Filling Problem	18	18
Device Markings/Labelling Problem	17	17
Collapse	16	16
Expiration Date Error	14	14
Noise, Audible	13	13
Appropriate Term/Code Not Available	12	12
Gas/Air Leak	12	12
Physical Resistance	12	12
Insufficient Flow or Under Infusion	12	12
Product Quality Problem	11	11
Torn Material	11	11
Unclear Information	11	11
Positioning Problem	10	10
Malposition of Device	10	10
Fitting Problem	9	9
Labelling, Instructions for Use or Training Problem	9	9
Improper Flow or Infusion	9	9
Manufacturing, Packaging or Shipping Problem	9	9
Therapeutic or Diagnostic Output Failure	8	8
Packaging Problem	8	8
Sharp Edges	8	8
Material Discolored	8	8
Incorrect, Inadequate or Imprecise Result or Readings	8	8
Material Separation	8	8
Blocked Connection	8	8
Aspiration Issue	7	7
Failure to Advance	7	7
Sticking	7	7
Material Too Rigid or Stiff	7	7

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3285	3285
No Known Impact Or Consequence To Patient	2455	2455
No Consequences Or Impact To Patient	2002	2002
No Patient Involvement	472	472
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	355	355
Pain	264	264
Urinary Tract Infection	195	195
No Information	186	186
Foreign Body In Patient	151	151
Patient Problem/Medical Problem	148	148
No Code Available	134	134
Discomfort	112	112
Hematuria	101	101
Urinary Retention	90	90
Hemorrhage/Bleeding	57	57
Unspecified Infection	47	47
Insufficient Information	47	47
Tissue Breakdown	23	23
Hypersensitivity/Allergic reaction	23	23
Device Embedded In Tissue or Plaque	22	22
Fistula	21	21
Reaction	19	19
Incontinence	16	16
Erosion	16	16
Injury	16	16
Perforation	14	14
Blood Loss	14	14
Abdominal Distention	14	14
Cancer	14	14
Skin Inflammation/ Irritation	12	12
Irritation	12	12
Abdominal Pain	10	10
Tissue Damage	10	10
Alteration In Body Temperature	10	10
Swelling	9	9
Exposure to Body Fluids	9	9
Inflammation	9	9
Muscle Spasm(s)	8	8
Bacterial Infection	8	8
Abrasion	8	8
Burning Sensation	8	8
Unspecified Gastrointestinal Problem	8	8
Distress	7	7
Pressure Sores	7	7
Death	7	7
Erythema	7	7
Fever	7	7
Laceration(s)	6	6
Rash	6	6
Confusion/ Disorientation	6	6
Irritability	6	6
Complaint, Ill-Defined	5	5
Sedation	4	4
Staphylococcus Aureus	4	4
Skin Discoloration	4	4
Micturition Urgency	4	4
Cramp(s) /Muscle Spasm(s)	4	4
Swelling/ Edema	4	4
Localized Skin Lesion	3	3
Sepsis	3	3
Local Reaction	3	3
Thrombus	3	3
Inadequate Pain Relief	3	3
Anxiety	3	3
Depression	2	2
Chills	2	2
Discharge	2	2
Skin Irritation	2	2
Hematoma	2	2
High Blood Pressure/ Hypertension	2	2
Purulent Discharge	2	2
Calcium Deposits/Calcification	2	2
Unspecified Tissue Injury	2	2
Skin Tears	2	2
Not Applicable	2	2
Convulsion/Seizure	2	2
Urethral Stenosis/Stricture	1	1
Genital Bleeding	1	1
Dysuria	1	1
Inadequate Osseointegration	1	1
Bowel Perforation	1	1
Test Result	1	1
Caustic/Chemical Burns	1	1
Vascular System (Circulation), Impaired	1	1
Obstruction/Occlusion	1	1
Spinal Cord Injury	1	1
Sweating	1	1
Respiratory Failure	1	1
Collapse	1	1
Loss of consciousness	1	1
Fungal Infection	1	1
Chest Pain	1	1
Cyst(s)	1	1
Dementia	1	1
Edema	1	1
Emotional Changes	1	1
Abscess	1	1
Anaphylactic Shock	1	1
Aneurysm	1	1
Bruise/Contusion	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	C.R. Bard Inc	II	Sep-23-2021
2	C.R. Bard, Inc.	II	Jun-06-2018
3	C.R. Bard, Inc., Urological Division	II	Sep-07-2012