TPLC - Total Product Life Cycle

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Device	syringe, balloon inflation
Regulation Description	Angiographic injector and syringe.
Product Code	MAV
Regulation Number	870.1650
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Leak/Splash	974	974
Loose or Intermittent Connection	202	202
Display or Visual Feedback Problem	144	144
Break	82	82
Physical Resistance/Sticking	45	45
Incorrect, Inadequate or Imprecise Result or Readings	44	44
Device Contamination with Chemical or Other Material	41	41
Inflation Problem	23	23
Material Separation	16	16
Unsealed Device Packaging	15	15
Improper or Incorrect Procedure or Method	12	12
Tear, Rip or Hole in Device Packaging	11	11
Deflation Problem	9	9
Packaging Problem	9	9
Appropriate Term/Code Not Available	8	8
Material Integrity Problem	8	8
Defective Device	6	6
Shipping Damage or Problem	6	6
Noise, Audible	6	6
Adverse Event Without Identified Device or Use Problem	6	6
Contamination	5	5
Product Quality Problem	5	5
Mechanical Problem	5	5
Device Contaminated During Manufacture or Shipping	4	4
Crack	4	4
Detachment of Device or Device Component	4	4
Unstable	3	3
Failure to Zero	3	3
Obstruction of Flow	3	3
Mechanical Jam	2	2
Pressure Problem	2	2
Insufficient Information	2	2
Difficult to Remove	2	2
Contamination /Decontamination Problem	2	2
Connection Problem	2	2
Device Sensing Problem	2	2
Difficult to Open or Remove Packaging Material	2	2
Output Problem	1	1
Fracture	1	1
Fluid/Blood Leak	1	1
Material Split, Cut or Torn	1	1
Material Rupture	1	1
Retraction Problem	1	1
Use of Device Problem	1	1
Suction Problem	1	1
Device Damaged Prior to Use	1	1
Low Readings	1	1
Moisture Damage	1	1
Deformation Due to Compressive Stress	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1257	1257
No Consequences Or Impact To Patient	90	90
Insufficient Information	14	14
Air Embolism	6	6
No Patient Involvement	6	6
No Known Impact Or Consequence To Patient	5	5
Laceration(s)	3	3
Arrhythmia	3	3
Cardiac Arrest	3	3
Low Blood Pressure/ Hypotension	3	3
Vascular Dissection	3	3
Hemorrhage/Bleeding	2	2
Perforation	1	1
Ventricular Fibrillation	1	1
Perforation of Vessels	1	1
Bradycardia	1	1
Thrombosis/Thrombus	1	1