TPLC - Total Product Life Cycle

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Device	apparatus, suction, single patient use, portable, nonpowered
Product Code	GCY
Regulation Number	878.4680
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	131	135
Disconnection	129	129
Dull, Blunt	102	102
Suction Failure	95	95
Material Fragmentation	60	60
Detachment of Device or Device Component	58	58
Device Contamination with Chemical or Other Material	53	56
Suction Problem	51	51
Inflation Problem	47	47
Fluid/Blood Leak	34	34
Burst Container or Vessel	20	20
Fracture	17	17
Material Split, Cut or Torn	17	17
Fitting Problem	16	16
Component Missing	15	15
Leak/Splash	15	15
Difficult to Remove	13	13
Material Rupture	12	12
Therapeutic or Diagnostic Output Failure	11	11
Pressure Problem	11	11
Product Quality Problem	10	10
Improper or Incorrect Procedure or Method	10	10
Incorrect Measurement	10	10
Entrapment of Device	10	10
Crack	10	10
Decrease in Suction	8	8
Material Separation	8	8
Device Damaged Prior to Use	8	8
Contamination /Decontamination Problem	8	8
Component Misassembled	8	8
Physical Resistance/Sticking	7	7
Partial Blockage	7	7
Restricted Flow rate	6	6
Gas/Air Leak	6	6
Tear, Rip or Hole in Device Packaging	6	6
Defective Device	5	5
Material Twisted/Bent	4	4
Complete Blockage	4	4
Use of Device Problem	4	4
Material Puncture/Hole	4	4
Misassembled	4	4
Delivered as Unsterile Product	4	4
Difficult to Insert	4	4
No Apparent Adverse Event	4	4
Insufficient Information	3	3
Appropriate Term/Code Not Available	3	3
Device Fell	3	3
Loose or Intermittent Connection	3	3
Unsealed Device Packaging	3	3
Collapse	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	403	403
No Consequences Or Impact To Patient	275	275
No Known Impact Or Consequence To Patient	200	200
Foreign Body In Patient	82	82
No Patient Involvement	65	68
Insufficient Information	30	30
Device Embedded In Tissue or Plaque	21	21
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	17	17
Exposure to Body Fluids	14	14
Unspecified Infection	11	11
Patient Problem/Medical Problem	11	11
Hematoma	8	8
Post Operative Wound Infection	8	8
No Information	6	10
Pain	5	5
No Code Available	4	4
Injury	3	3
Irritation	2	2
Laceration(s)	2	2
Unspecified Tissue Injury	2	2
Bruise/Contusion	2	2
Abdominal Pain	1	1
Foreign Body Sensation in Eye	1	1
Impaired Healing	1	1
Hypersensitivity/Allergic reaction	1	1
Pneumothorax	1	1
Failure of Implant	1	1
Skin Irritation	1	1
Skin Inflammation/ Irritation	1	1
Blood Loss	1	1
Fever	1	1
Discomfort	1	1
Abscess	1	1
Fluid Discharge	1	1
Joint Laxity	1	1
Tissue Damage	1	1
Hemorrhage/Bleeding	1	1