TPLC - Total Product Life Cycle

• Device: catheter, nephrostomy, general & plastic surgery
• Product Code: GBO
• Regulation Number: 878.4200
• Device Class: 1

MDR Year	MDR Reports	MDR Events
2019	175	175
2020	127	127
2021	115	115
2022	121	121
2023	153	153
2024	10	10

Device Problems	MDRs with this Device Problem	Events in those MDRs
Difficult to Remove	157	157
Fluid/Blood Leak	109	109
Leak/Splash	95	95
Material Separation	89	89
Adverse Event Without Identified Device or Use Problem	70	70
Detachment of Device or Device Component	50	50
Break	38	38
Difficult to Advance	35	35
Gas/Air Leak	19	19
Material Deformation	17	17
Tear, Rip or Hole in Device Packaging	14	14
Obstruction of Flow	13	13
Device Contaminated During Manufacture or Shipping	13	13
Material Twisted/Bent	10	10
Failure to Advance	9	9
Unsealed Device Packaging	9	9
Crack	7	7
Device Dislodged or Dislocated	7	7
Material Split, Cut or Torn	5	5
Migration or Expulsion of Device	5	5
Fracture	5	5
Complete Blockage	4	4
Material Puncture/Hole	4	4
Defective Device	4	4
Separation Problem	4	4
Deformation Due to Compressive Stress	4	4
Defective Component	3	3
Physical Resistance/Sticking	3	3
Migration	3	3
Use of Device Problem	3	3
Improper or Incorrect Procedure or Method	3	3
Entrapment of Device	3	3
Material Frayed	2	2
Difficult to Insert	2	2
Nonstandard Device	2	2
Delivered as Unsterile Product	2	2
Patient-Device Incompatibility	2	2
Inadequacy of Device Shape and/or Size	2	2
Stretched	2	2
Appropriate Term/Code Not Available	2	2
Patient Device Interaction Problem	2	2
Output Problem	2	2
Infusion or Flow Problem	2	2
Device-Device Incompatibility	2	2
Device Contamination with Chemical or Other Material	2	2
No Pressure	1	1
Component Missing	1	1
Connection Problem	1	1
Expulsion	1	1
Device Damaged by Another Device	1	1
Packaging Problem	1	1
Therapeutic or Diagnostic Output Failure	1	1
Insufficient Information	1	1
Air/Gas in Device	1	1
Unraveled Material	1	1
Product Quality Problem	1	1
Material Rupture	1	1
Insufficient Flow or Under Infusion	1	1
Fitting Problem	1	1
Mechanical Problem	1	1
Material Fragmentation	1	1
Restricted Flow rate	1	1
Flushing Problem	1	1
Difficult to Fold, Unfold or Collapse	1	1
Contamination	1	1
Disconnection	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	254	254
No Known Impact Or Consequence To Patient	181	181
No Code Available	67	67
Insufficient Information	43	43
No Consequences Or Impact To Patient	41	41
No Patient Involvement	23	23
Foreign Body In Patient	19	19
Pain	17	17
Pneumothorax	14	14
Sepsis	14	14
Hemorrhage/Bleeding	14	14
Failure of Implant	8	8
Discomfort	8	8
Obstruction/Occlusion	8	8
No Information	7	7
Renal Failure	7	7
Pleural Effusion	6	6
Inflammation	5	5
Septic Shock	5	5
Perforation	5	5
Urinary Tract Infection	5	5
Respiratory Failure	3	3
Hematuria	3	3
Pseudoaneurysm	3	3
Urinary Retention	3	3
Pneumonia	3	3
Death	3	3
Abscess	2	2
Unspecified Infection	2	2
Fistula	2	2
Post Operative Wound Infection	2	2
Device Embedded In Tissue or Plaque	2	2
Convulsion/Seizure	1	1
Respiratory Insufficiency	1	1
Unspecified Kidney or Urinary Problem	1	1
Low Oxygen Saturation	1	1
Loss of consciousness	1	1
Bowel Perforation	1	1
Fluid Discharge	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Hematoma	1	1
Hemothorax	1	1
Low Blood Pressure/ Hypotension	1	1
Hypovolemic Shock	1	1
Air Embolism	1	1
Aneurysm	1	1
Bacterial Infection	1	1
Erosion	1	1
Bradycardia	1	1
Cardiac Arrest	1	1
Fever	1	1
Pulmonary Embolism	1	1
Abdominal Pain	1	1
Respiratory Distress	1	1
Liver Damage/Dysfunction	1	1
Internal Organ Perforation	1	1
Paralysis	1	1
Rupture	1	1
Tachycardia	1	1
Transient Ischemic Attack	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Cook Inc.	II	Jan-16-2020