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
Material Twisted/Bent	10	10
Unsealed Device Packaging	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
Deformation Due to Compressive Stress	4	4
Defective Device	4	4
Material Puncture/Hole	4	4
Complete Blockage	4	4
Separation Problem	4	4
Physical Resistance/Sticking	4	4
Defective Component	3	3
Improper or Incorrect Procedure or Method	3	3
Use of Device Problem	3	3
Migration	3	3
Entrapment of Device	3	3
Patient-Device Incompatibility	2	2
Material Frayed	2	2
Patient Device Interaction Problem	2	2
Nonstandard Device	2	2
Difficult to Insert	2	2
Stretched	2	2
Appropriate Term/Code Not Available	2	2
Device-Device Incompatibility	2	2
Device Contamination with Chemical or Other Material	2	2
Infusion or Flow Problem	2	2
Delivered as Unsterile Product	2	2
Output Problem	2	2
Packaging Problem	2	2
Inadequacy of Device Shape and/or Size	2	2
Disconnection	1	1
Connection Problem	1	1
Flushing Problem	1	1
Fitting Problem	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	46	46
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
Pneumothorax	14	14
Sepsis	14	14
Failure of Implant	8	8
Discomfort	8	8
Obstruction/Occlusion	8	8
Renal Failure	7	7
No Information	7	7
Pleural Effusion	6	6
Urinary Tract Infection	5	5
Septic Shock	5	5
Inflammation	5	5
Perforation	5	5
Pseudoaneurysm	3	3
Pneumonia	3	3
Urinary Retention	3	3
Hematuria	3	3
Respiratory Failure	3	3
Death	3	3
Post Operative Wound Infection	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Abscess	2	2
Unspecified Infection	2	2
Fistula	2	2
Device Embedded In Tissue or Plaque	2	2
Loss of consciousness	1	1
Respiratory Insufficiency	1	1
Hemothorax	1	1
Low Blood Pressure/ Hypotension	1	1
Internal Organ Perforation	1	1
Low Oxygen Saturation	1	1
Pulmonary Embolism	1	1
Erosion	1	1
Bacterial Infection	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