TPLC - Total Product Life Cycle

show TPLC since

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	139	139
Dull, Blunt	106	106
Suction Failure	89	89
Device Contamination with Chemical or Other Material	82	82
Break	73	74
Material Fragmentation	73	73
Fluid/Blood Leak	35	36
Inflation Problem	30	30
Detachment of Device or Device Component	29	29
Material Split, Cut or Torn	27	28
Suction Problem	24	24
Component Missing	16	16
Fracture	15	16
Decrease in Suction	13	14
Component Misassembled	12	12
Fitting Problem	12	12
Difficult to Remove	11	11
Entrapment of Device	11	11
Burst Container or Vessel	11	11
Leak/Splash	11	11
Crack	10	10
Product Quality Problem	10	10
Incorrect Measurement	10	10
Defective Device	9	9
Pressure Problem	9	9
Therapeutic or Diagnostic Output Failure	7	7
Partial Blockage	7	7
Material Separation	7	7
Tear, Rip or Hole in Device Packaging	7	7
Contamination /Decontamination Problem	6	6
Device Contaminated During Manufacture or Shipping	6	6
Material Rupture	6	6
Unsealed Device Packaging	5	5
Output Problem	5	5
Physical Resistance/Sticking	5	5
Material Twisted/Bent	5	5
Device Damaged Prior to Use	4	4
Restricted Flow rate	4	4
Nonstandard Device	4	4
No Apparent Adverse Event	4	4
Difficult to Insert	4	4
Use of Device Problem	4	4
Insufficient Information	3	3
Difficult to Open or Close	3	3
Complete Blockage	3	3
Incomplete or Missing Packaging	3	3
Contamination	3	3
Obstruction of Flow	3	3
Adverse Event Without Identified Device or Use Problem	3	3
Delivered as Unsterile Product	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	571	573
No Consequences Or Impact To Patient	166	166
No Known Impact Or Consequence To Patient	80	80
Foreign Body In Patient	66	66
Insufficient Information	33	33
No Patient Involvement	28	28
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	24	26
Exposure to Body Fluids	16	16
Unspecified Infection	12	12
Hematoma	12	13
Device Embedded In Tissue or Plaque	10	10
Post Operative Wound Infection	8	8
Patient Problem/Medical Problem	5	5
No Code Available	3	3
Pain	3	3
Injury	3	3
Bruise/Contusion	2	2
Granuloma	2	2
Bacterial Infection	2	2
Abscess	2	2
Laceration(s)	2	2
Irritation	2	2
Tissue Breakdown	1	1
Pressure Sores	1	1
Hemorrhage/Bleeding	1	1
Joint Laxity	1	1
Fluid Discharge	1	1
Discomfort	1	1
Seroma	1	1
Cellulitis	1	1
Blood Loss	1	1
Purulent Discharge	1	1
Anemia	1	1
Muscle Weakness	1	1
Inflammation	1	1
Skin Inflammation/ Irritation	1	1
No Information	1	1
Skin Irritation	1	1
Sepsis	1	1
Failure of Implant	1	1
Pneumothorax	1	1
Hypersensitivity/Allergic reaction	1	1
Wound Dehiscence	1	1
Impaired Healing	1	1