TPLC - Total Product Life Cycle

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Device	sterilant, medical devices
Regulation Description	Liquid chemical sterilants/high level disinfectants.
Product Code	MED
Regulation Number	880.6885
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Leak/Splash	16	21
Use of Device Problem	14	14
Fluid/Blood Leak	10	15
Adverse Event Without Identified Device or Use Problem	8	8
Improper or Incorrect Procedure or Method	7	7
Insufficient Information	5	5
Break	4	4
Failure to Disinfect	3	3
Device Handling Problem	3	3
Chemical Problem	2	2
Fire	1	1
Power Problem	1	1
Unintended Movement	1	1
No Apparent Adverse Event	1	1
Failure to Align	1	1
Deformation Due to Compressive Stress	1	1
Mechanical Problem	1	1
Device Emits Odor	1	1
Material Too Rigid or Stiff	1	1
Shipping Damage or Problem	1	1
Explosion	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	38	48
Insufficient Information	8	8
Skin Discoloration	4	4
Burn(s)	4	4
Burning Sensation	4	4
Chemical Exposure	3	3
Nasal Obstruction	3	3
Anaphylactic Shock	3	3
Skin Burning Sensation	3	3
Hypersensitivity/Allergic reaction	2	2
Wheezing	2	2
Skin Inflammation/ Irritation	2	2
Eye Burn	2	2
Unspecified Eye / Vision Problem	2	2
Dyspnea	2	2
Bronchospasm	2	2
Cough	2	2
Swelling/ Edema	2	2
Blurred Vision	2	2
Caustic/Chemical Burns	2	2
Headache	2	2
Low Blood Pressure/ Hypotension	2	2
Superficial (First Degree) Burn	1	1
Syncope/Fainting	1	1
Decreased Sensitivity	1	1
Red Eye(s)	1	1
Corneal Abrasion	1	1
Aspiration/Inhalation	1	1
Asthma	1	1
Erythema	1	1
Pain	1	1
Unspecified Respiratory Problem	1	1
No Consequences Or Impact To Patient	1	1
Sore Throat	1	1
Eye Pain	1	1
Excessive Tear Production	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Mckesson Medical-Surgical Inc. Corporate Office	II	Aug-26-2022