TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Deflation Problem	1140	1140
Burst Container or Vessel	983	983
Fluid/Blood Leak	881	881
Difficult to Remove	743	743
Material Puncture/Hole	502	502
Decrease in Pressure	497	497
Failure to Infuse	457	457
Partial Blockage	377	377
Inflation Problem	354	354
Break	336	336
Leak/Splash	317	317
Material Rupture	317	317
Inaccurate Flow Rate	308	308
Device Dislodged or Dislocated	219	219
Material Fragmentation	219	219
Adverse Event Without Identified Device or Use Problem	199	199
Erratic or Intermittent Display	163	163
Device Fell	154	154
No Flow	142	142
Material Split, Cut or Torn	132	132
Component Missing	131	131
Component Falling	126	126
Device Operates Differently Than Expected	106	106
Patient Device Interaction Problem	97	97
Device Sensing Problem	92	92
Device Slipped	78	78
Biocompatibility	75	75
Obstruction of Flow	75	75
Component Misassembled	71	71
Material Deformation	67	67
Incorrect Measurement	66	66
Disconnection	66	66
Detachment of Device or Device Component	65	65
Material Invagination	59	59
Illegible Information	56	56
Device Contamination with Chemical or Other Material	55	55
Inadequate or Insufficient Training	55	55
Patient-Device Incompatibility	55	55
Difficult to Insert	54	54
Complete Blockage	53	53
Hole In Material	52	52
Calcified	50	50
Detachment Of Device Component	50	50
Tear, Rip or Hole in Device Packaging	43	43
Material Twisted/Bent	42	42
Dent in Material	40	40
Deformation Due to Compressive Stress	40	40
Device Handling Problem	39	39
Use of Device Problem	38	38
Inadequate Instructions for Healthcare Professional	38	38

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3699	3699
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	380	380
Pain	275	275
Urinary Tract Infection	199	199
No Information	186	186
Foreign Body In Patient	165	165
Patient Problem/Medical Problem	148	148
No Code Available	134	134
Discomfort	119	119
Hematuria	103	103
Urinary Retention	93	93
Hemorrhage/Bleeding	59	59
Unspecified Infection	49	49
Insufficient Information	48	48
Hypersensitivity/Allergic reaction	27	27
Tissue Breakdown	24	24
Device Embedded In Tissue or Plaque	22	22
Fistula	21	21
Reaction	19	19
Incontinence	18	18
Injury	16	16
Erosion	16	16
Cancer	14	14
Blood Loss	14	14
Abdominal Distention	14	14
Perforation	14	14
Skin Inflammation/ Irritation	13	13
Abdominal Pain	13	13
Irritation	12	12
Tissue Damage	10	10
Alteration In Body Temperature	10	10
Exposure to Body Fluids	10	10
Inflammation	9	9
Swelling	9	9
Bacterial Infection	8	8
Abrasion	8	8
Unspecified Gastrointestinal Problem	8	8
Burning Sensation	8	8
Muscle Spasm(s)	8	8
Pressure Sores	7	7
Fever	7	7
Death	7	7
Distress	7	7
Erythema	7	7
Swelling/ Edema	6	6
Laceration(s)	6	6
Irritability	6	6

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