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	106	106
Dull, Blunt	106	106
Suction Failure	85	85
Break	69	69
Material Fragmentation	61	61
Device Contamination with Chemical or Other Material	55	55
Inflation Problem	30	30
Fluid/Blood Leak	26	26
Detachment of Device or Device Component	24	24
Suction Problem	24	24
Material Split, Cut or Torn	20	20
Component Missing	16	16
Fracture	14	14
Burst Container or Vessel	11	11
Difficult to Remove	11	11
Fitting Problem	11	11
Entrapment of Device	10	10
Component Misassembled	10	10
Product Quality Problem	10	10
Leak/Splash	10	10
Crack	9	9
Pressure Problem	9	9
Incorrect Measurement	9	9
Decrease in Suction	8	8
Therapeutic or Diagnostic Output Failure	7	7
Tear, Rip or Hole in Device Packaging	7	7
Material Separation	7	7
Contamination /Decontamination Problem	6	6
Material Rupture	6	6
Physical Resistance/Sticking	5	5
Unsealed Device Packaging	5	5
Partial Blockage	5	5
Device Damaged Prior to Use	4	4
No Apparent Adverse Event	4	4
Defective Device	4	4
Device Contaminated During Manufacture or Shipping	4	4
Difficult to Insert	4	4
Restricted Flow rate	3	3
Output Problem	3	3
Insufficient Information	3	3
Material Twisted/Bent	3	3
Deformation Due to Compressive Stress	2	2
Difficult to Open or Close	2	2
Failure to Infuse	2	2
Delivered as Unsterile Product	2	2
Misassembled	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Obstruction of Flow	2	2
Use of Device Problem	2	2
Inadequate Instructions for Healthcare Professional	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	452	452
No Consequences Or Impact To Patient	166	166
No Known Impact Or Consequence To Patient	80	80
Foreign Body In Patient	63	63
Insufficient Information	31	31
No Patient Involvement	28	28
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	20	20
Exposure to Body Fluids	14	14
Unspecified Infection	11	11
Device Embedded In Tissue or Plaque	10	10
Hematoma	9	9
Post Operative Wound Infection	8	8
Patient Problem/Medical Problem	5	5
No Code Available	3	3
Injury	3	3
Pain	3	3
Irritation	2	2
Laceration(s)	2	2
Abscess	2	2
Unspecified Tissue Injury	2	2
Bruise/Contusion	2	2
Impaired Healing	1	1
Wound Dehiscence	1	1
Hypersensitivity/Allergic reaction	1	1
Pneumothorax	1	1
Failure of Implant	1	1
Skin Irritation	1	1
No Information	1	1
Skin Inflammation/ Irritation	1	1
Inflammation	1	1
Anemia	1	1
Purulent Discharge	1	1
Blood Loss	1	1
Cellulitis	1	1
Seroma	1	1
Discomfort	1	1
Fluid Discharge	1	1
Joint Laxity	1	1
Hemorrhage/Bleeding	1	1