TPLC - Total Product Life Cycle

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Device	applicator, absorbent tipped, non-sterile
Product Code	KXF
Regulation Number	880.6025
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	71	71
Contamination /Decontamination Problem	62	62
Defective Device	19	19
Contamination	15	15
Break	13	13
Material Separation	13	13
Defective Component	10	10
Detachment of Device or Device Component	8	8
Device Markings/Labelling Problem	5	5
Manufacturing, Packaging or Shipping Problem	4	4
Insufficient Information	4	4
Device Fell	4	4
Appropriate Term/Code Not Available	3	3
Packaging Problem	3	3
Missing Information	3	3
Labelling, Instructions for Use or Training Problem	3	3
Material Fragmentation	2	2
Patient-Device Incompatibility	2	2
No Apparent Adverse Event	2	2
Patient Device Interaction Problem	1	1
Physical Resistance/Sticking	1	1
Sharp Edges	1	1
Separation Problem	1	1
Illegible Information	1	1
Inaccurate Information	1	1
Loss of or Failure to Bond	1	1
Burst Container or Vessel	1	1
Disconnection	1	1
Entrapment of Device	1	1
Fire	1	1
Fluid/Blood Leak	1	1
Leak/Splash	1	1
Loose or Intermittent Connection	1	1
Device Emits Odor	1	1
Particulates	1	1
Product Quality Problem	1	1
Device Appears to Trigger Rejection	1	1
Difficult to Remove	1	1
Material Integrity Problem	1	1
Output Problem	1	1
Device Contamination with Chemical or Other Material	1	1
Device Ingredient or Reagent Problem	1	1
Residue After Decontamination	1	1
Malposition of Device	1	1
Device Slipped	1	1
Use of Device Problem	1	1
Improper or Incorrect Procedure or Method	1	1
Material Perforation	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	72	72
No Known Impact Or Consequence To Patient	48	48
Reaction	34	34
Hypersensitivity/Allergic reaction	22	22
Foreign Body In Patient	21	21
Insufficient Information	7	7
Unspecified Infection	6	6
Abrasion	6	6
Laceration(s)	4	4
Rash	4	4
Irritation	3	3
Pain	3	3
Not Applicable	3	3
Burn(s)	2	2
Burning Sensation	2	2
No Consequences Or Impact To Patient	2	2
Rupture	1	1
Malaise	1	1
Impaired Healing	1	1
Meningitis	1	1
Skin Irritation	1	1
Tinnitus	1	1
Nausea	1	1
Nerve Damage	1	1
Cerebrospinal Fluid Leakage	1	1
Fatigue	1	1
Headache	1	1
Hearing Impairment	1	1
Hearing Loss	1	1
Hemorrhage/Bleeding	1	1
Airway Obstruction	1	1
Respiratory Arrest	1	1
Skin Inflammation/ Irritation	1	1
Needle Stick/Puncture	1	1
Burn, Thermal	1	1
Blood Loss	1	1
Patient Problem/Medical Problem	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Avanos Medical, Inc.	II	Apr-19-2023