TPLC - Total Product Life Cycle

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Device	catheter, ureteral, gastro-urology
Regulation Description	Urological catheter and accessories.
Product Code	EYB
Regulation Number	876.5130
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Burst Container or Vessel	9	9
Device Contaminated During Manufacture or Shipping	6	6
Material Puncture/Hole	5	5
Adverse Event Without Identified Device or Use Problem	5	5
Material Fragmentation	4	4
Device Markings/Labelling Problem	3	3
Material Twisted/Bent	3	3
Inflation Problem	3	3
Nonstandard Device	3	3
Leak/Splash	2	2
Material Split, Cut or Torn	2	2
Manufacturing, Packaging or Shipping Problem	2	2
Deflation Problem	2	2
Patient Device Interaction Problem	2	2
Material Rupture	2	2
Inaccurate Information	2	2
Fitting Problem	1	1
Break	1	1
Difficult to Open or Remove Packaging Material	1	1
Wrong Label	1	1
Unsealed Device Packaging	1	1
Defective Device	1	1
Contamination /Decontamination Problem	1	1
Degraded	1	1
Difficult to Insert	1	1
Inaccurate Flow Rate	1	1
Sharp Edges	1	1
Packaging Problem	1	1
Incorrect Measurement	1	1
Material Separation	1	1
Detachment of Device or Device Component	1	1
Component Misassembled	1	1
Appropriate Term/Code Not Available	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	51	51
Foreign Body In Patient	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Laceration(s)	2	2
Blister	1	1
Rash	1	1
Needle Stick/Puncture	1	1
Insufficient Information	1	1
Renal Impairment	1	1
Kidney Infection	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Hobbs Medical, Inc.	II	Oct-07-2022