TPLC - Total Product Life Cycle

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Device	apparatus, suction, single patient use, portable, nonpowered
Product Code	GCY
Regulation Number	878.4680
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Dull, Blunt	102	102
Disconnection	101	101
Suction Failure	83	83
Break	68	68
Material Fragmentation	57	57
Device Contamination with Chemical or Other Material	52	52
Inflation Problem	30	30
Fluid/Blood Leak	26	26
Detachment of Device or Device Component	24	24
Suction Problem	24	24
Material Split, Cut or Torn	18	18
Component Missing	15	15
Fracture	13	13
Burst Container or Vessel	11	11
Difficult to Remove	11	11
Leak/Splash	10	10
Fitting Problem	10	10
Entrapment of Device	10	10
Product Quality Problem	10	10
Pressure Problem	9	9
Crack	9	9
Component Misassembled	8	8
Incorrect Measurement	8	8
Therapeutic or Diagnostic Output Failure	7	7
Decrease in Suction	7	7
Material Separation	7	7
Tear, Rip or Hole in Device Packaging	7	7
Contamination /Decontamination Problem	6	6
Material Rupture	6	6
Partial Blockage	5	5
Physical Resistance/Sticking	5	5
Defective Device	4	4
Unsealed Device Packaging	4	4
Difficult to Insert	4	4
Device Damaged Prior to Use	4	4
No Apparent Adverse Event	4	4
Device Contaminated During Manufacture or Shipping	4	4
Insufficient Information	3	3
Material Twisted/Bent	3	3
Restricted Flow rate	3	3
Output Problem	3	3
Deformation Due to Compressive Stress	2	2
Difficult to Open or Close	2	2
Inadequate Instructions for Healthcare Professional	2	2
Material Puncture/Hole	2	2
Use of Device Problem	2	2
Device Markings/Labelling Problem	2	2
Obstruction of Flow	2	2
Failure to Infuse	2	2
Adverse Event Without Identified Device or Use Problem	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	427	427
No Consequences Or Impact To Patient	166	166
No Known Impact Or Consequence To Patient	80	80
Foreign Body In Patient	61	61
Insufficient Information	30	30
No Patient Involvement	28	28
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	19	19
Exposure to Body Fluids	14	14
Unspecified Infection	10	10
Device Embedded In Tissue or Plaque	10	10
Post Operative Wound Infection	8	8
Hematoma	7	7
Patient Problem/Medical Problem	5	5
No Code Available	3	3
Injury	3	3
Pain	3	3
Irritation	2	2
Laceration(s)	2	2
Unspecified Tissue Injury	2	2
Bruise/Contusion	2	2
Pneumothorax	1	1
Hypersensitivity/Allergic reaction	1	1
Failure of Implant	1	1
Skin Irritation	1	1
No Information	1	1
Skin Inflammation/ Irritation	1	1
Blood Loss	1	1
Abscess	1	1
Fluid Discharge	1	1
Joint Laxity	1	1
Hemorrhage/Bleeding	1	1