TPLC - Total Product Life Cycle

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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Difficult to Remove	158	158
Fluid/Blood Leak	109	109
Leak/Splash	95	95
Material Separation	90	90
Adverse Event Without Identified Device or Use Problem	70	70
Detachment of Device or Device Component	53	53
Break	40	40
Difficult to Advance	35	35
Gas/Air Leak	19	19
Material Deformation	17	17
Tear, Rip or Hole in Device Packaging	14	14
Device Contaminated During Manufacture or Shipping	13	13
Obstruction of Flow	13	13
Unsealed Device Packaging	10	10
Material Twisted/Bent	10	10
Failure to Advance	9	9
Device Dislodged or Dislocated	7	7
Crack	7	7
Fracture	5	5
Material Split, Cut or Torn	5	5
Migration or Expulsion of Device	5	5
Defective Device	4	4
Material Puncture/Hole	4	4
Complete Blockage	4	4
Deformation Due to Compressive Stress	4	4
Separation Problem	4	4
Defective Component	3	3
Improper or Incorrect Procedure or Method	3	3
Physical Resistance/Sticking	3	3
Entrapment of Device	3	3
Use of Device Problem	3	3
Migration	3	3
Packaging Problem	2	2
Delivered as Unsterile Product	2	2
Patient-Device Incompatibility	2	2
Material Frayed	2	2
Device-Device Incompatibility	2	2
Device Contamination with Chemical or Other Material	2	2
Inadequacy of Device Shape and/or Size	2	2
Patient Device Interaction Problem	2	2
Output Problem	2	2
Nonstandard Device	2	2
Appropriate Term/Code Not Available	2	2
Infusion or Flow Problem	2	2
Stretched	2	2
Difficult to Insert	2	2
Product Quality Problem	1	1
Component Missing	1	1
Contamination	1	1
Air/Gas in Device	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	264	264
No Known Impact Or Consequence To Patient	181	181
No Code Available	67	67
Insufficient Information	45	45
No Consequences Or Impact To Patient	41	41
No Patient Involvement	23	23
Foreign Body In Patient	21	21
Pain	17	17
Hemorrhage/Bleeding	14	14
Sepsis	14	14
Pneumothorax	14	14
Failure of Implant	8	8
Obstruction/Occlusion	8	8
Discomfort	8	8
No Information	7	7
Renal Failure	7	7
Pleural Effusion	6	6
Inflammation	5	5
Perforation	5	5
Urinary Tract Infection	5	5
Septic Shock	5	5
Hematuria	3	3
Respiratory Failure	3	3
Death	3	3
Urinary Retention	3	3
Pneumonia	3	3
Pseudoaneurysm	3	3
Device Embedded In Tissue or Plaque	2	2
Post Operative Wound Infection	2	2
Fistula	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Abscess	2	2
Unspecified Infection	2	2
Internal Organ Perforation	1	1
Hemothorax	1	1
Low Blood Pressure/ Hypotension	1	1
Low Oxygen Saturation	1	1
Respiratory Insufficiency	1	1
Erosion	1	1
Loss of consciousness	1	1
Bacterial Infection	1	1
Pulmonary Embolism	1	1
Convulsion/Seizure	1	1
Aneurysm	1	1
Tachycardia	1	1
Fluid Discharge	1	1
Bradycardia	1	1
Unspecified Kidney or Urinary Problem	1	1
Paralysis	1	1
Fever	1	1

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