TPLC - Total Product Life Cycle

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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Disconnection	129	129
Device Contamination with Chemical or Other Material	76	76
Suction Failure	76	76
Material Fragmentation	62	62
Dull, Blunt	54	54
Break	53	54
Fluid/Blood Leak	35	36
Material Split, Cut or Torn	27	28
Detachment of Device or Device Component	23	23
Decrease in Suction	19	20
Fracture	11	12
Leak/Splash	11	11
Component Missing	11	11
Component Misassembled	10	10
Inflation Problem	10	10
Entrapment of Device	10	10
Product Quality Problem	10	10
Nonstandard Device	9	9
Fitting Problem	9	9
Defective Device	9	9
Suction Problem	8	8
Partial Blockage	8	8
Crack	7	7
Insufficient Information	7	7
Tear, Rip or Hole in Device Packaging	6	6
Device Contaminated During Manufacture or Shipping	6	6
Difficult to Remove	6	6
Incorrect Measurement	5	5
Unsealed Device Packaging	4	4
Restricted Flow rate	4	4
Material Twisted/Bent	4	4
No Apparent Adverse Event	4	4
Physical Resistance/Sticking	4	4
Material Too Soft/Flexible	3	3
Output Problem	3	3
Therapeutic or Diagnostic Output Failure	3	3
Incomplete or Missing Packaging	3	3
Burst Container or Vessel	3	3
Complete Blockage	3	3
Use of Device Problem	3	3
Material Separation	2	2
Device Damaged Prior to Use	2	2
Defective Component	2	2
Collapse	2	2
Contamination	2	2
Inadequate Instructions for Healthcare Professional	2	2
Loose or Intermittent Connection	2	2
Obstruction of Flow	2	2
Deformation Due to Compressive Stress	2	2
Contamination /Decontamination Problem	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	563	565
Foreign Body In Patient	54	54
No Consequences Or Impact To Patient	29	29
Insufficient Information	26	26
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	23	25
Exposure to Body Fluids	15	15
Hematoma	12	13
Unspecified Infection	9	9
Post Operative Wound Infection	8	8
Device Embedded In Tissue or Plaque	7	7
No Patient Involvement	5	5
Laceration(s)	2	2
Pain	2	2
Bacterial Infection	2	2
Granuloma	2	2
Impaired Healing	1	1
Wound Dehiscence	1	1
Hypersensitivity/Allergic reaction	1	1
Pneumothorax	1	1
Sepsis	1	1
No Code Available	1	1
Skin Inflammation/ Irritation	1	1
Inflammation	1	1
Muscle Weakness	1	1
Anemia	1	1
Purulent Discharge	1	1
Cellulitis	1	1
Seroma	1	1
Injury	1	1
Discomfort	1	1
Abscess	1	1
Fluid Discharge	1	1
Joint Laxity	1	1
Swelling/ Edema	1	1
Hemorrhage/Bleeding	1	1
Pressure Sores	1	1
Tissue Breakdown	1	1