TPLC - Total Product Life Cycle

show TPLC since

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	1173	1173
Break	547	548
Material Separation	450	450
Fluid/Blood Leak	382	382
Defective Component	362	362
Leak/Splash	175	175
Material Integrity Problem	168	168
Adverse Event Without Identified Device or Use Problem	148	151
Infusion or Flow Problem	99	99
Device Contaminated During Manufacture or Shipping	97	97
Material Fragmentation	90	90
Dull, Blunt	71	73
Device Contamination with Chemical or Other Material	71	71
Disconnection	47	47
Deformation Due to Compressive Stress	43	43
Unraveled Material	34	34
Detachment of Device or Device Component	32	32
Obstruction of Flow	29	29
Device Damaged Prior to Use	26	26
Wrong Label	26	26
No Apparent Adverse Event	25	25
Difficult to Remove	25	25
Suction Problem	24	24
Component Misassembled	24	24
Material Puncture/Hole	23	23
Suction Failure	22	22
Material Twisted/Bent	21	21
Nonstandard Device	19	19
Failure to Advance	19	19
Material Split, Cut or Torn	19	19
Contamination /Decontamination Problem	17	17
Material Too Soft/Flexible	16	16
Restricted Flow rate	15	15
Entrapment of Device	15	15
Difficult to Insert	14	14
Air/Gas in Device	14	14
Incorrect Measurement	14	14
Crack	12	12
Difficult to Fold, Unfold or Collapse	12	12
Use of Device Problem	11	11
Fitting Problem	11	11
Physical Resistance/Sticking	10	10
Device Dislodged or Dislocated	10	10
Malposition of Device	9	9
Component Missing	9	9
Material Deformation	9	9
Packaging Problem	8	8
Appropriate Term/Code Not Available	8	8
Improper or Incorrect Procedure or Method	8	8
Contamination	7	7

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2987	2988
Foreign Body In Patient	215	215
No Consequences Or Impact To Patient	120	120
Insufficient Information	96	96
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	80	83
Unspecified Infection	46	46
Pain	34	34
Hemorrhage/Bleeding	31	31
Hematoma	29	29
No Known Impact Or Consequence To Patient	27	27
Extravasation	27	27
Pneumothorax	26	26
No Patient Involvement	23	23
Seroma	22	22
Endophthalmitis	21	24
Failure to Anastomose	19	19
Fistula	14	14
Wound Dehiscence	13	13
No Code Available	13	13
Not Applicable	12	12
Post Operative Wound Infection	11	11
Necrosis	10	10
Inflammation	9	10
Pleural Effusion	8	8
Bacterial Infection	8	8
Failure of Implant	8	8
Toxic Anterior Segment Syndrome (TASS)	8	11
Pneumonia	8	8
Abscess	8	8
Obstruction/Occlusion	7	7
Device Embedded In Tissue or Plaque	7	7
Unspecified Tissue Injury	6	8
Cardiac Tamponade	6	6
Thrombosis/Thrombus	6	6
Sepsis	5	5
Discomfort	5	5
Erythema	5	5
Fever	5	5
Atrial Fibrillation	4	4
Hypoxia	4	4
Infiltration into Tissue	4	4
Capsular Bag Tear	4	4
Cardiac Arrest	4	4
Low Blood Pressure/ Hypotension	4	4
Abdominal Pain	4	4
Impaired Healing	4	4
Uveitis	4	7
Fluid Discharge	3	3
Numbness	3	3
Low Oxygen Saturation	3	3