TPLC - Total Product Life Cycle

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Device	catheter, irrigation
Regulation Description	Introduction/drainage catheter and accessories.
Product Code	GBX
Regulation Number	878.4200
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fracture	1323	1323
Material Separation	612	612
Break	610	611
Fluid/Blood Leak	461	461
Defective Component	359	359
Material Integrity Problem	219	219
Nonstandard Device	194	197
Leak/Splash	189	189
Adverse Event Without Identified Device or Use Problem	152	155
Infusion or Flow Problem	104	104
Device Contaminated During Manufacture or Shipping	101	101
Material Fragmentation	88	88
Device Contamination with Chemical or Other Material	71	71
Deformation Due to Compressive Stress	58	58
Dull, Blunt	46	48
Disconnection	43	43
Obstruction of Flow	39	39
Unraveled Material	36	36
Difficult to Remove	28	28
Material Twisted/Bent	27	27
Detachment of Device or Device Component	27	27
Wrong Label	26	26
Device Damaged Prior to Use	26	26
Suction Problem	25	25
No Apparent Adverse Event	25	25
Material Puncture/Hole	24	24
Component Misassembled	23	23
Failure to Advance	22	22
Suction Failure	22	22
Material Split, Cut or Torn	20	20
Air/Gas in Device	17	17
Material Too Soft/Flexible	17	17
Difficult to Fold, Unfold or Collapse	16	16
Incorrect Measurement	16	16
Restricted Flow rate	16	16
Entrapment of Device	16	16
Difficult to Insert	16	16
Device Dislodged or Dislocated	15	15
Improper or Incorrect Procedure or Method	14	14
Physical Resistance/Sticking	13	13
Packaging Problem	12	12
Fitting Problem	12	12
Component Missing	11	11
Use of Device Problem	11	11
Malposition of Device	9	9
Material Deformation	8	8
Migration	8	8
Loose or Intermittent Connection	8	8
Tear, Rip or Hole in Device Packaging	7	7
Connection Problem	7	7

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3530	3534
Foreign Body In Patient	212	212
Insufficient Information	105	105
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	74	77
Unspecified Infection	49	49
Pain	32	32
Extravasation	32	32
Hemorrhage/Bleeding	32	32
Pneumothorax	31	31
Hematoma	29	29
Seroma	25	25
Failure to Anastomose	19	19
Endophthalmitis	18	21
Fistula	14	14
Post Operative Wound Infection	14	14
No Consequences Or Impact To Patient	13	13
Wound Dehiscence	12	12
Necrosis	11	11
Pleural Effusion	10	10
Inflammation	9	10
Abscess	8	8
Failure of Implant	8	8
Pneumonia	8	8
Toxic Anterior Segment Syndrome (TASS)	8	11
Bacterial Infection	8	8
Obstruction/Occlusion	7	7
No Patient Involvement	6	6
Thrombosis/Thrombus	6	6
Cardiac Tamponade	6	6
Cardiac Arrest	6	6
Unspecified Tissue Injury	6	8
Fever	5	5
Sepsis	5	5
Erythema	5	5
Impaired Healing	5	5
Discomfort	5	5
Hypoxia	4	4
Swelling/ Edema	4	4
Atrial Fibrillation	4	4
Capsular Bag Tear	4	4
Infiltration into Tissue	4	4
Low Blood Pressure/ Hypotension	4	4
Low Oxygen Saturation	4	4
Uveitis	4	7
Abdominal Pain	4	4
Cellulitis	3	3
Tachycardia	3	3
Fluid Discharge	3	3
No Code Available	3	3
Internal Organ Perforation	3	3