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	1156	1156
2024	399	399

Device Problems	MDRs with this Device Problem	Events in those MDRs
Deflation Problem	1129	1129
Burst Container or Vessel	983	983
Fluid/Blood Leak	861	861
Difficult to Remove	716	716
Decrease in Pressure	497	497
Failure to Infuse	453	453
Material Puncture/Hole	443	443
Partial Blockage	372	372
Inflation Problem	339	339
Break	336	336
Leak/Splash	317	317
Inaccurate Flow Rate	296	296
Material Rupture	248	248
Device Dislodged or Dislocated	218	218
Material Fragmentation	208	208
Adverse Event Without Identified Device or Use Problem	199	199
Erratic or Intermittent Display	161	161
Device Fell	154	154
No Flow	142	142
Material Split, Cut or Torn	129	129
Component Missing	126	126
Component Falling	126	126
Device Operates Differently Than Expected	106	106
Patient Device Interaction Problem	94	94
Device Sensing Problem	81	81
Device Slipped	78	78
Obstruction of Flow	75	75
Biocompatibility	74	74
Component Misassembled	69	69
Material Deformation	67	67
Detachment of Device or Device Component	65	65
Disconnection	64	64
Incorrect Measurement	63	63
Material Invagination	59	59
Illegible Information	56	56
Patient-Device Incompatibility	55	55
Inadequate or Insufficient Training	55	55
Difficult to Insert	54	54
Device Contamination with Chemical or Other Material	53	53
Hole In Material	52	52
Complete Blockage	52	52
Detachment Of Device Component	50	50
Calcified	50	50
Material Twisted/Bent	41	41
Tear, Rip or Hole in Device Packaging	39	39
Inadequate Instructions for Healthcare Professional	38	38
Deformation Due to Compressive Stress	38	38
Use of Device Problem	38	38
Misassembled	38	38
Dent in Material	37	37
Device Handling Problem	36	36
Device Damaged Prior to Use	34	34
Short Fill	34	34
Insufficient Information	33	33
Inability to Irrigate	31	31
Restricted Flow rate	30	30
Gel Leak	30	30
Physical Resistance/Sticking	30	30
Missing Information	29	29
Nonstandard Device	28	28
Improper or Incorrect Procedure or Method	27	27
Material Integrity Problem	27	27
Fracture	27	27
Defective Component	26	26
No Display/Image	26	26
Defective Device	24	24
Inadequacy of Device Shape and/or Size	23	23
Naturally Worn	22	22
Infusion or Flow Problem	19	19
Filling Problem	18	18
Crack	18	18
Material Protrusion/Extrusion	18	18
Device Markings/Labelling Problem	17	17
Collapse	16	16
Expiration Date Error	14	14
Noise, Audible	13	13
Insufficient Flow or Under Infusion	12	12
Gas/Air Leak	12	12
Physical Resistance	12	12
Appropriate Term/Code Not Available	12	12
Product Quality Problem	11	11
Torn Material	11	11
Unclear Information	11	11
Positioning Problem	10	10
Malposition of Device	10	10
Manufacturing, Packaging or Shipping Problem	9	9
Labelling, Instructions for Use or Training Problem	9	9
Improper Flow or Infusion	9	9
Fitting Problem	9	9
Material Separation	8	8
Blocked Connection	8	8
Incorrect, Inadequate or Imprecise Result or Readings	8	8
Packaging Problem	8	8
Sharp Edges	8	8
Material Discolored	8	8
Therapeutic or Diagnostic Output Failure	8	8
No Apparent Adverse Event	7	7
Degraded	7	7
Occlusion Within Device	7	7
Failure to Advance	7	7

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3461	3461
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	363	363
Pain	270	270
Urinary Tract Infection	196	196
No Information	186	186
Foreign Body In Patient	155	155
Patient Problem/Medical Problem	148	148
No Code Available	134	134
Discomfort	116	116
Hematuria	102	102
Urinary Retention	91	91
Hemorrhage/Bleeding	58	58
Unspecified Infection	48	48
Insufficient Information	47	47
Tissue Breakdown	24	24
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	13	13
Irritation	12	12
Abdominal Pain	11	11
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
Cramp(s) /Muscle Spasm(s)	5	5
Swelling/ Edema	5	5
Skin Discoloration	5	5
Complaint, Ill-Defined	5	5
Sedation	4	4
Staphylococcus Aureus	4	4
Micturition Urgency	4	4
Sepsis	3	3
Local Reaction	3	3
Thrombus	3	3
Inadequate Pain Relief	3	3
Anxiety	3	3
Localized Skin Lesion	3	3
Unspecified Tissue Injury	3	3
Obstruction/Occlusion	2	2
Skin Tears	2	2
Not Applicable	2	2
Convulsion/Seizure	2	2
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
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
Hypoglycemia	1	1
Low Blood Pressure/ Hypotension	1	1
Failure of Implant	1	1
Hemorrhage, Extradural	1	1
Nausea	1	1
Internal Organ Perforation	1	1
Itching Sensation	1	1
Respiratory Distress	1	1
Pulmonary Infarction	1	1
Uterine Perforation	1	1
Abnormal Vaginal Discharge	1	1
Thrombosis	1	1
Ulceration	1	1
Excessive Tear Production	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