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	140	140
Device Contamination with Chemical or Other Material	76	76
Suction Failure	73	73
Material Fragmentation	62	62
Dull, Blunt	50	50
Fluid/Blood Leak	34	35
Break	29	29
Material Split, Cut or Torn	25	26
Decrease in Suction	17	18
Nonstandard Device	11	11
Fracture	11	12
Component Misassembled	10	10
Fitting Problem	9	9
Component Missing	9	9
Inflation Problem	9	9
Insufficient Device Problem Information	8	8
Partial Blockage	8	8
Suction Problem	7	7
Tear, Rip or Hole in Device Packaging	6	6
Device Contaminated During Manufacture or Shipping	6	6
Detachment of Device or Device Component	6	6
Crack	6	6
Defective Device	5	5
Incorrect Measurement	5	5
Material Too Soft/Flexible	4	4
No Apparent Adverse Event	4	4
Material Twisted/Bent	4	4
Restricted Flow rate	4	4
Complete Blockage	4	4
Unsealed Device Packaging	4	4
Burst Container or Vessel	3	3
Incomplete or Missing Packaging	3	3
Collapse	2	2
Material Separation	2	2
Difficult to Remove	2	2
Inadequate Instructions for Healthcare Professional	2	2
Deformation Due to Compressive Stress	2	2
Device Dislodged or Dislocated	2	2
Leak/Splash	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Scratched Material	2	2
Obstruction of Flow	2	2
Patient Device Interaction Problem	2	2
Device Damaged Prior to Use	2	2
Use of Device Problem	2	2
Inadequacy of Device Shape and/or Size	1	1
Device Damaged Prior to Receipt by User	1	1
Material Rupture	1	1
Material Puncture/Hole	1	1
Off-Label Use	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	580	582
Foreign Body In Patient	57	57
No Consequences Or Impact To Patient	29	29
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	27	29
Insufficient Information	26	26
Exposure to Body Fluids	23	23
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
Pain	3	3
Laceration(s)	2	2
Bacterial Infection	2	2
Granuloma	2	2
Inflammation	1	1
Hypersensitivity/Allergic reaction	1	1
Anemia	1	1
Wound Dehiscence	1	1
No Code Available	1	1
Hemorrhage/Blood Loss/Bleeding	1	1
Impaired Healing	1	1
Purulent Discharge	1	1
Unspecified Tissue Injury	1	1
Fluid Discharge	1	1
Muscle Weakness/Atrophy	1	1
Abscess	1	1
Cellulitis	1	1
Seroma	1	1
Tissue Breakdown	1	1
Pneumothorax	1	1
Sepsis	1	1
Joint Laxity	1	1
Pressure Sore/Ulcer	1	1
Skin Inflammation/ Irritation	1	1
Discomfort	1	1
Swelling/ Edema	1	1
Injury	1	1
Colitis	1	1