TPLC - Total Product Life Cycle

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Device	container, liquid medication, graduated
Regulation Description	Liquid medication dispenser.
Product Code	KYW
Regulation Number	880.6430
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Device Contamination with Chemical or Other Material	12	12
Device Markings/Labelling Problem	10	10
Patient Device Interaction Problem	9	9
Fluid/Blood Leak	9	9
Volume Accuracy Problem	9	9
Contamination /Decontamination Problem	5	5
Leak/Splash	4	4
Physical Resistance/Sticking	4	4
Contamination	3	3
Defective Component	3	3
Patient-Device Incompatibility	2	2
Failure to Deliver	2	2
Packaging Problem	2	2
Sharp Edges	1	1
Missing Information	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Material Deformation	1	1
Mechanical Jam	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Obstruction of Flow	1	1
Expiration Date Error	1	1
Fungus in Device Environment	1	1
Labelling, Instructions for Use or Training Problem	1	1
Disconnection	1	1
Break	1	1
Complete Blockage	1	1
Loose or Intermittent Connection	1	1
Delivered as Unsterile Product	1	1
Product Quality Problem	1	1
Difficult to Remove	1	1
Shipping Damage or Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	79	79
Pulmonary Emphysema	5	5
Insufficient Information	3	3
Pneumonia	2	2
Unspecified Infection	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Pneumothorax	1	1
Aspiration/Inhalation	1	1
Reaction to Medicinal Component of Device	1	1
Fever	1	1
Dehydration	1	1
Dyspnea	1	1
Tachycardia	1	1
No Consequences Or Impact To Patient	1	1
Airway Obstruction	1	1