TPLC - Total Product Life Cycle

show TPLC since

Device	catheter, conduction, anesthetic
Product Code	BSO
Regulation Number	868.5120
Device Class	2

Premarket Reviews
Manufacturer	Decision
B. BRAUN MEDICAL INC
	SUBSTANTIALLY EQUIVALENT	1
B. BRAUN MEDICAL INC.
	SUBSTANTIALLY EQUIVALENT	2
B. BRAUN MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
BAXANO, INC.
	SUBSTANTIALLY EQUIVALENT	1
BUSSE HOSPITAL DISPOSABLES
	SUBSTANTIALLY EQUIVALENT	1
CIMPAX APS
	SUBSTANTIALLY EQUIVALENT	1
EPIMED INTERNATIONAL INC.
	SUBSTANTIALLY EQUIVALENT	1
EPIMED INTERNATIONAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
FERROSAN MEDICAL DEVICES SP. Z O.O.
	SUBSTANTIALLY EQUIVALENT	1
HALYARD HEALTH
	SUBSTANTIALLY EQUIVALENT	1
HK SURGICAL
	SUBSTANTIALLY EQUIVALENT	1
IMEDICOM CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
KIMBERLY-CLARK CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
MEDLINE INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	2
PAJUNK GMBH MEDIZINTECHNOLOGIE
	SUBSTANTIALLY EQUIVALENT	2
PLAN 1 HEALTH, S.R.L.
	SUBSTANTIALLY EQUIVALENT	1
SUMMIT MEDICAL PRODUCTS, INC
	SUBSTANTIALLY EQUIVALENT	2
TELEFLEX MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
TELEFLEX MEDICAL , INC.
	SUBSTANTIALLY EQUIVALENT	1
TELEFLEX, INC.
	SUBSTANTIALLY EQUIVALENT	1
VITAL 5
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	818	818
Obstruction of Flow	92	92
Detachment of Device or Device Component	75	75
Fluid/Blood Leak	70	70
Difficult to Advance	68	68
Adverse Event Without Identified Device or Use Problem	54	54
No Flow	53	53
Material Twisted/Bent	52	52
Material Separation	38	38
Device Handling Problem	28	28
Physical Resistance/Sticking	27	27
Failure to Advance	25	25
Difficult to Remove	25	25
Material Fragmentation	23	23
Device Operates Differently Than Expected	22	22
Material Split, Cut or Torn	19	19
Fracture	18	18
Leak/Splash	17	17
Disconnection	17	17
Torn Material	17	17
Device Damaged by Another Device	16	16
Stretched	14	14
Split	14	14
Detachment Of Device Component	12	12
Human Factors Issue	12	12
Improper or Incorrect Procedure or Method	11	11
Entrapment of Device	10	10
Crack	10	10
Unsealed Device Packaging	10	10
Use of Device Problem	9	9
Retraction Problem	8	8
Device Issue	8	8
Loose or Intermittent Connection	8	8
Material Integrity Problem	8	8
Defective Device	7	7
Activation, Positioning or Separation Problem	7	7
Premature Separation	7	7
Positioning Problem	6	6
Component Missing	6	6
Mechanical Problem	6	6
Device Dislodged or Dislocated	6	6
Patient-Device Incompatibility	5	5
Connection Problem	5	5
Product Quality Problem	5	5
Shipping Damage or Problem	5	5
Burst Container or Vessel	5	5
Material Rupture	5	5
Kinked	4	4
Unraveled Material	4	4
Device Or Device Fragments Location Unknown	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Patient Involvement	528	528
No Clinical Signs, Symptoms or Conditions	304	304
No Consequences Or Impact To Patient	293	293
Foreign Body In Patient	109	109
No Information	103	103
Device Embedded In Tissue or Plaque	71	71
No Known Impact Or Consequence To Patient	63	63
Insufficient Information	45	45
Not Applicable	33	33
Unspecified Infection	31	31
Pain	25	25
Awareness during Anaesthesia	19	19
No Code Available	14	14
Needle Stick/Puncture	10	10
Inadequate Pain Relief	7	7
Erythema	6	6
Bacterial Infection	5	5
Headache	4	4
Reaction	4	4
Discomfort	4	4
Tissue Damage	3	3
Swelling/ Edema	3	3
Purulent Discharge	3	3
Patient Problem/Medical Problem	3	3
Swelling	3	3
Death	3	3
Fever	3	3
Hemothorax	2	2
Hemorrhage/Bleeding	2	2
Toxicity	2	2
Skin Inflammation	2	2
Pregnancy	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Injury	2	2
Rash	2	2
Spinal Column Injury	2	2
Cellulitis	2	2
Cardiac Arrest	2	2
Other (for use when an appropriate patient code cannot be identified)	2	2
Local Reaction	2	2
Itching Sensation	2	2
Embolism/Embolus	2	2
Hematoma	2	2
Decreased Sensitivity	1	1
Distress	1	1
Pulmonary Embolism	1	1
Decreased Respiratory Rate	1	1
Low Oxygen Saturation	1	1
Low Blood Pressure/ Hypotension	1	1
Nausea	1	1