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	117	117
Suction Failure	76	76
Device Contamination with Chemical or Other Material	75	75
Material Fragmentation	60	60
Break	52	53
Dull, Blunt	52	52
Fluid/Blood Leak	33	34
Material Split, Cut or Torn	24	25
Detachment of Device or Device Component	22	22
Decrease in Suction	15	16
Leak/Splash	11	11
Component Missing	11	11
Product Quality Problem	10	10
Inflation Problem	10	10
Component Misassembled	10	10
Fracture	10	11
Fitting Problem	9	9
Entrapment of Device	9	9
Defective Device	9	9
Crack	7	7
Suction Problem	7	7
Device Contaminated During Manufacture or Shipping	6	6
Tear, Rip or Hole in Device Packaging	6	6
Partial Blockage	6	6
Difficult to Remove	6	6
Incorrect Measurement	5	5
No Apparent Adverse Event	4	4
Material Twisted/Bent	4	4
Nonstandard Device	4	4
Unsealed Device Packaging	4	4
Restricted Flow rate	4	4
Physical Resistance/Sticking	4	4
Therapeutic or Diagnostic Output Failure	3	3
Use of Device Problem	3	3
Output Problem	3	3
Incomplete or Missing Packaging	3	3
Burst Container or Vessel	3	3
Inadequate Instructions for Healthcare Professional	2	2
Contamination	2	2
Contamination /Decontamination Problem	2	2
Device Dislodged or Dislocated	2	2
Material Too Soft/Flexible	2	2
Obstruction of Flow	2	2
Insufficient Information	2	2
Deformation Due to Compressive Stress	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Complete Blockage	2	2
Device Damaged Prior to Use	2	2
Material Separation	2	2
Difficult to Open or Close	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	531	533
Foreign Body In Patient	53	53
No Consequences Or Impact To Patient	29	29
Insufficient Information	24	24
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	21	23
Exposure to Body Fluids	15	15
Hematoma	10	11
Unspecified Infection	9	9
Post Operative Wound Infection	8	8
Device Embedded In Tissue or Plaque	6	6
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
Hemorrhage/Bleeding	1	1
Pressure Sores	1	1
Tissue Breakdown	1	1