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	1354	1354
Material Separation	637	637
Break	602	603
Fluid/Blood Leak	472	472
Defective Component	359	359
Material Integrity Problem	228	228
Nonstandard Device	211	214
Leak/Splash	189	189
Adverse Event Without Identified Device or Use Problem	152	155
Device Contaminated During Manufacture or Shipping	104	104
Infusion or Flow Problem	104	104
Material Fragmentation	84	84
Device Contamination with Chemical or Other Material	70	70
Deformation Due to Compressive Stress	59	59
Obstruction of Flow	44	44
Dull, Blunt	43	45
Disconnection	41	41
Unraveled Material	35	35
Difficult to Remove	29	29
Material Twisted/Bent	27	27
Wrong Label	26	26
Device Damaged Prior to Use	26	26
No Apparent Adverse Event	25	25
Material Puncture/Hole	24	24
Suction Problem	24	24
Component Misassembled	23	23
Failure to Advance	21	21
Suction Failure	21	21
Detachment of Device or Device Component	20	20
Difficult to Insert	19	19
Material Split, Cut or Torn	19	19
Restricted Flow rate	18	18
Incorrect Measurement	17	17
Material Too Soft/Flexible	17	17
Air/Gas in Device	17	17
Difficult to Fold, Unfold or Collapse	16	16
Improper or Incorrect Procedure or Method	13	13
Device Dislodged or Dislocated	13	13
Packaging Problem	12	12
Use of Device Problem	12	12
Fitting Problem	12	12
Component Missing	11	11
Physical Resistance/Sticking	10	10
Malposition of Device	9	9
Loose or Intermittent Connection	8	8
Decrease in Suction	8	8
Material Deformation	8	8
Migration	7	7
Connection Problem	7	7
Difficult to Flush	7	7

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3627	3631
Foreign Body In Patient	217	217
Insufficient Information	106	106
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	74	77
Unspecified Infection	49	49
Extravasation	32	32
Hemorrhage/Blood Loss/Bleeding	32	32
Pain	32	32
Pneumothorax	32	32
Hematoma	29	29
Seroma	25	25
Failure to Anastomose	19	19
Endophthalmitis	18	21
Post Operative Wound Infection	14	14
Fistula	14	14
No Consequences Or Impact To Patient	13	13
Wound Dehiscence	12	12
Necrosis	11	11
Pleural Effusion	10	10
Inflammation	9	10
Pneumonia	8	8
Failure of Implant	8	8
Bacterial Infection	8	8
Abscess	8	8
Toxic Anterior Segment Syndrome (TASS)	8	11
Obstruction/Occlusion	7	7
Cardiac Tamponade	7	7
Cardiac Arrest	7	7
Unspecified Tissue Injury	6	8
No Patient Involvement	6	6
Thrombosis/Thrombus	6	6
Erythema	5	5
Sepsis	5	5
Discomfort	5	5
Impaired Healing	5	5
Fever	5	5
Abdominal Pain	4	4
Low Blood Pressure/ Hypotension	4	4
Infiltration into Tissue	4	4
Atrial Fibrillation	4	4
Internal Organ Perforation	4	4
Capsular Bag Tear	4	4
Low Oxygen Saturation	4	4
Hypoxia	4	4
Uveitis	4	7
Swelling/ Edema	4	4
Tachycardia	3	3
Hernia	3	3
Cellulitis	3	3
Conjunctivitis	3	5