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
Fracture	11	12
Nonstandard Device	11	11
Component Misassembled	10	10
Fitting Problem	9	9
Inflation Problem	9	9
Component Missing	9	9
Insufficient Device Problem Information	8	8
Partial Blockage	8	8
Suction Problem	7	7
Detachment of Device or Device Component	6	6
Tear, Rip or Hole in Device Packaging	6	6
Device Contaminated During Manufacture or Shipping	6	6
Crack	6	6
Incorrect Measurement	5	5
Defective Device	5	5
Material Twisted/Bent	4	4
Complete Blockage	4	4
No Apparent Adverse Event	4	4
Restricted Flow rate	4	4
Unsealed Device Packaging	4	4
Material Too Soft/Flexible	4	4
Burst Container or Vessel	3	3
Incomplete or Missing Packaging	3	3
Adverse Event Without Identified Device or Use Problem	2	2
Device Damaged Prior to Use	2	2
Difficult to Remove	2	2
Leak/Splash	2	2
Deformation Due to Compressive Stress	2	2
Collapse	2	2
Obstruction of Flow	2	2
Material Separation	2	2
Device Dislodged or Dislocated	2	2
Scratched Material	2	2
Inadequate Instructions for Healthcare Professional	2	2
Patient Device Interaction Problem	2	2
Use of Device Problem	2	2
Output Problem	1	1
Material Integrity Problem	1	1
Inadequacy of Device Shape and/or Size	1	1
Contamination /Decontamination Problem	1	1
Biocompatibility	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
Muscle Weakness/Atrophy	1	1
Wound Dehiscence	1	1
Unspecified Tissue Injury	1	1
Joint Laxity	1	1
Impaired Healing	1	1
Purulent Discharge	1	1
Cellulitis	1	1
Fluid Discharge	1	1
Sepsis	1	1
Abscess	1	1
No Code Available	1	1
Colitis	1	1
Tissue Breakdown	1	1
Injury	1	1
Anemia	1	1
Hemorrhage/Blood Loss/Bleeding	1	1
Pressure Sore/Ulcer	1	1
Swelling/ Edema	1	1
Discomfort	1	1
Seroma	1	1
Pneumothorax	1	1
Skin Inflammation/ Irritation	1	1