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	12	12
Material Puncture/Hole	6	6
Adverse Event Without Identified Device or Use Problem	6	6
Device Contaminated During Manufacture or Shipping	5	5
Incorrect Measurement	5	5
Material Fragmentation	4	4
Material Twisted/Bent	4	4
Device Markings/Labelling Problem	3	3
Deflation Problem	3	3
Inflation Problem	3	3
Manufacturing, Packaging or Shipping Problem	2	2
Patient Device Interaction Problem	2	2
Inaccurate Flow Rate	2	2
Nonstandard Device	2	2
Inaccurate Information	2	2
Leak/Splash	1	1
Fitting Problem	1	1
Break	1	1
Difficult to Open or Remove Packaging Material	1	1
Patient-Device Incompatibility	1	1
Wrong Label	1	1
Unsealed Device Packaging	1	1
Defective Component	1	1
Defective Device	1	1
Contamination /Decontamination Problem	1	1
Degraded	1	1
Misassembled	1	1
Material Rupture	1	1
Packaging Problem	1	1
Component Misassembled	1	1
Appropriate Term/Code Not Available	1	1
Deformation Due to Compressive Stress	1	1
No Flow	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	45	45
No Known Impact Or Consequence To Patient	7	7
No Consequences Or Impact To Patient	6	6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
No Patient Involvement	2	2
Laceration(s)	2	2
Blister	1	1
Rash	1	1
Foreign Body In Patient	1	1
Discomfort	1	1
Insufficient Information	1	1
Pain	1	1
Renal Impairment	1	1
Kidney Infection	1	1

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