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	119	119
Dull, Blunt	107	107
Suction Failure	87	87
Break	71	71
Device Contamination with Chemical or Other Material	66	66
Material Fragmentation	65	65
Inflation Problem	30	30
Fluid/Blood Leak	29	29
Detachment of Device or Device Component	24	24
Suction Problem	24	24
Material Split, Cut or Torn	21	21
Component Missing	16	16
Fracture	14	14
Component Misassembled	12	12
Fitting Problem	12	12
Burst Container or Vessel	11	11
Difficult to Remove	11	11
Entrapment of Device	10	10
Product Quality Problem	10	10
Incorrect Measurement	10	10
Leak/Splash	10	10
Crack	9	9
Pressure Problem	9	9
Decrease in Suction	9	9
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
Defective Device	5	5
Device Contaminated During Manufacture or Shipping	5	5
Partial Blockage	5	5
Material Twisted/Bent	5	5
Restricted Flow rate	4	4
Device Damaged Prior to Use	4	4
No Apparent Adverse Event	4	4
Difficult to Insert	4	4
Difficult to Open or Close	3	3
Output Problem	3	3
Insufficient Information	3	3
Contamination	3	3
Obstruction of Flow	3	3
Material Too Soft/Flexible	2	2
Deformation Due to Compressive Stress	2	2
Device Dislodged or Dislocated	2	2
Failure to Infuse	2	2
Delivered as Unsterile Product	2	2
Misassembled	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	503	503
No Consequences Or Impact To Patient	166	166
No Known Impact Or Consequence To Patient	80	80
Foreign Body In Patient	64	64
Insufficient Information	31	31
No Patient Involvement	28	28
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	20	20
Exposure to Body Fluids	15	15
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
Pneumothorax	1	1
Hypersensitivity/Allergic reaction	1	1
Wound Dehiscence	1	1
Failure of Implant	1	1
Skin Irritation	1	1
No Information	1	1
Skin Inflammation/ Irritation	1	1
Inflammation	1	1
Muscle Weakness	1	1
Blood Loss	1	1
Anemia	1	1
Purulent Discharge	1	1
Cellulitis	1	1
Seroma	1	1
Discomfort	1	1
Fluid Discharge	1	1
Joint Laxity	1	1
Hemorrhage/Bleeding	1	1