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
CIMPAX APS
	SUBSTANTIALLY EQUIVALENT	1
EPIMED INTERNATIONAL INC.
	SUBSTANTIALLY EQUIVALENT	1
HK SURGICAL
	SUBSTANTIALLY EQUIVALENT	1
1. K193664 SubQKath Catheter and Needle Set
MEDLINE INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
TELEFLEX MEDICAL
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	753	753
Obstruction of Flow	85	85
Fluid/Blood Leak	67	67
Detachment of Device or Device Component	66	66
Difficult to Advance	66	66
Material Twisted/Bent	49	49
No Flow	47	47
Material Separation	36	36
Failure to Advance	25	25
Adverse Event Without Identified Device or Use Problem	19	19
Difficult to Remove	19	19
Physical Resistance/Sticking	18	18
Material Split, Cut or Torn	17	17
Material Fragmentation	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
Shipping Damage or Problem	5	5
Burst Container or Vessel	5	5
Loose or Intermittent Connection	4	4
Material Rupture	4	4
Packaging Problem	4	4
Component Missing	4	4
Defective Device	4	4
Unraveled Material	3	3
Device Damaged Prior to Use	3	3
Material Puncture/Hole	3	3
Product Quality Problem	3	3
Complete Blockage	3	3
Entrapment of Device	3	3
Material Too Soft/Flexible	3	3
Premature Separation	3	3
Separation Problem	2	2
Contamination	2	2
Mechanical Problem	2	2
Flushing Problem	2	2
Defective Component	2	2
Dull, Blunt	2	2
Connection Problem	2	2
Device Contamination with Body Fluid	2	2
Unintended Movement	2	2
Material Deformation	2	2
Mechanical Jam	2	2
Device Dislodged or Dislocated	2	2
Device Contamination with Chemical or Other Material	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Patient Involvement	526	526
No Clinical Signs, Symptoms or Conditions	309	309
No Consequences Or Impact To Patient	233	233
Foreign Body In Patient	90	90
No Information	62	62
Insufficient Information	45	45
Not Applicable	33	33
Device Embedded In Tissue or Plaque	25	25
No Known Impact Or Consequence To Patient	23	23
Pain	16	16
Needle Stick/Puncture	10	10
Unspecified Infection	7	7
Headache	4	4
Bacterial Infection	3	3
Swelling/ Edema	3	3
No Code Available	3	3
Discomfort	3	3
Inadequate Pain Relief	2	2
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