TPLC - Total Product Life Cycle

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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
1. K231242 Perifix FX Catheter; Contiplex FX Catheter
CIMPAX APS
	SUBSTANTIALLY EQUIVALENT	1
EPIMED INTERNATIONAL INC.
	SUBSTANTIALLY EQUIVALENT	1
HK SURGICAL
	SUBSTANTIALLY EQUIVALENT	1
MEDLINE INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
TELEFLEX MEDICAL
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	756	756
Obstruction of Flow	85	85
Fluid/Blood Leak	68	68
Detachment of Device or Device Component	66	66
Difficult to Advance	66	66
Material Twisted/Bent	49	49
No Flow	47	47
Material Separation	40	40
Failure to Advance	25	25
Physical Resistance/Sticking	20	20
Adverse Event Without Identified Device or Use Problem	19	19
Difficult to Remove	19	19
Material Fragmentation	18	18
Material Split, Cut or Torn	17	17
Disconnection	12	12
Leak/Splash	11	11
Crack	10	10
Unsealed Device Packaging	10	10
Fracture	9	9
Stretched	8	8
Activation, Positioning or Separation Problem	7	7
Material Integrity Problem	7	7
Burst Container or Vessel	5	5
Material Rupture	5	5
Defective Device	5	5
Shipping Damage or Problem	5	5
Loose or Intermittent Connection	4	4
Packaging Problem	4	4
Component Missing	4	4
Premature Separation	3	3
Material Too Soft/Flexible	3	3
Product Quality Problem	3	3
Unraveled Material	3	3
Entrapment of Device	3	3
Material Puncture/Hole	3	3
Complete Blockage	3	3
Device Damaged Prior to Use	3	3
Dull, Blunt	2	2
Separation Problem	2	2
Mechanical Jam	2	2
Contamination	2	2
Defective Component	2	2
Unintended Movement	2	2
Gas/Air Leak	2	2
Mechanical Problem	2	2
Connection Problem	2	2
Flushing Problem	2	2
Device Dislodged or Dislocated	2	2
Material Deformation	2	2
Device Contamination with Body Fluid	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Patient Involvement	526	526
No Clinical Signs, Symptoms or Conditions	316	316
No Consequences Or Impact To Patient	233	233
Foreign Body In Patient	94	94
No Information	62	62
Insufficient Information	46	46
Not Applicable	33	33
Device Embedded In Tissue or Plaque	25	25
No Known Impact Or Consequence To Patient	23	23
Pain	17	17
Needle Stick/Puncture	10	10
Unspecified Infection	7	7
Headache	4	4
Inadequate Pain Relief	3	3
Bacterial Infection	3	3
Swelling/ Edema	3	3
No Code Available	3	3
Discomfort	3	3
Hemorrhage/Bleeding	2	2
Paresthesia	2	2
Spinal Column Injury	2	2
Embolism/Embolus	2	2
Hematoma	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Patient Problem/Medical Problem	2	2
Cellulitis	1	1
Cramp(s) /Muscle Spasm(s)	1	1
Purulent Discharge	1	1
Burn(s)	1	1
Fever	1	1
Perforation	1	1
Vomiting	1	1
Muscle Weakness	1	1
Awareness during Anaesthesia	1	1
Dyspnea	1	1
Abscess	1	1
Sedation	1	1
Tachycardia	1	1
Unspecified Tissue Injury	1	1
Fungal Infection	1	1
Cerebrospinal Fluid Leakage	1	1
Convulsion/Seizure	1	1
Sepsis	1	1
Decreased Sensitivity	1	1
Hypersensitivity/Allergic reaction	1	1
Neuropathy	1	1
Respiratory Insufficiency	1	1
Low Oxygen Saturation	1	1
Pulmonary Embolism	1	1
Distress	1	1