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	149	149
Device Contamination with Chemical or Other Material	76	76
Suction Failure	73	73
Material Fragmentation	63	63
Dull, Blunt	51	51
Fluid/Blood Leak	34	35
Break	29	29
Material Split, Cut or Torn	28	29
Decrease in Suction	19	20
Nonstandard Device	12	12
Fitting Problem	11	11
Fracture	11	12
Component Misassembled	10	10
Component Missing	10	10
Inflation Problem	9	9
Partial Blockage	8	8
Insufficient Device Problem Information	8	8
Suction Problem	7	7
Device Contaminated During Manufacture or Shipping	6	6
Crack	6	6
Detachment of Device or Device Component	6	6
Tear, Rip or Hole in Device Packaging	6	6
Incorrect Measurement	6	6
Defective Device	5	5
Material Too Soft/Flexible	4	4
Restricted Flow rate	4	4
Complete Blockage	4	4
Unsealed Device Packaging	4	4
No Apparent Adverse Event	4	4
Material Twisted/Bent	4	4
Burst Container or Vessel	3	3
Incomplete or Missing Packaging	3	3
Patient Device Interaction Problem	3	3
Deformation Due to Compressive Stress	2	2
Device Dislodged or Dislocated	2	2
Material Separation	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Obstruction of Flow	2	2
Use of Device Problem	2	2
Scratched Material	2	2
Difficult to Remove	2	2
Inadequate Instructions for Healthcare Professional	2	2
Collapse	2	2
Device Damaged Prior to Use	2	2
Leak/Splash	2	2
Decrease in Pressure	1	1
Gas/Air Leak	1	1
Sharp Edges	1	1
Material Rupture	1	1
Contamination /Decontamination Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	595	597
Foreign Body In Patient	58	58
No Consequences Or Impact To Patient	29	29
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	29	31
Insufficient Information	26	26
Exposure to Body Fluids	23	23
Hematoma	13	14
Unspecified Infection	9	9
Post Operative Wound Infection	8	8
Device Embedded In Tissue or Plaque	7	7
No Patient Involvement	5	5
Pain	4	4
Laceration(s)	2	2
Swelling/ Edema	2	2
Bacterial Infection	2	2
Granuloma	2	2
Muscle Weakness/Atrophy	1	1
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
Anemia	1	1
Purulent Discharge	1	1
Cellulitis	1	1
Colitis	1	1
Seroma	1	1
Injury	1	1
Discomfort	1	1
Hemorrhage/Blood Loss/Bleeding	1	1
Pressure Sore/Ulcer	1	1
Abscess	1	1
Fluid Discharge	1	1
Joint Laxity	1	1
Unspecified Tissue Injury	1	1
Tissue Breakdown	1	1