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
Packaging Problem	9	9
Deflation Problem	9	9
Material Integrity Problem	8	8
Appropriate Term/Code Not Available	8	8
Adverse Event Without Identified Device or Use Problem	6	6
Defective Device	6	6
Noise, Audible	6	6
Shipping Damage or Problem	6	6
Product Quality Problem	5	5
Contamination	5	5
Mechanical Problem	5	5
Detachment of Device or Device Component	4	4
Crack	4	4
Device Contaminated During Manufacture or Shipping	4	4
Failure to Zero	3	3
Unstable	3	3
Obstruction of Flow	3	3
Insufficient Information	2	2
Difficult to Remove	2	2
Pressure Problem	2	2
Contamination /Decontamination Problem	2	2
Connection Problem	2	2
Mechanical Jam	2	2
Device Sensing Problem	2	2
Difficult to Open or Remove Packaging Material	2	2
Use of Device Problem	1	1
Suction Problem	1	1
Device Damaged Prior to Use	1	1
Material Rupture	1	1
Fracture	1	1
Fluid/Blood Leak	1	1
Moisture Damage	1	1
Material Split, Cut or Torn	1	1
Retraction Problem	1	1
Low Readings	1	1
Output Problem	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