TPLC - Total Product Life Cycle

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Device	drape, surgical, exempt
Regulation Description	Surgical drape and drape accessories.
Definition	This product code is the class II exempt counterpart of KKX, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 878.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description.
Product Code	PUI
Regulation Number	878.4370
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Puncture/Hole	135	135
Product Quality Problem	14	14
Material Integrity Problem	13	13
Contamination	13	13
Loss of or Failure to Bond	8	8
Leak/Splash	7	7
Material Perforation	7	7
Adverse Event Without Identified Device or Use Problem	6	6
No Apparent Adverse Event	5	5
Material Separation	5	5
Break	4	4
Fluid/Blood Leak	4	4
Flaked	4	4
Patient-Device Incompatibility	4	4
Melted	4	4
Accessory Incompatible	3	3
Material Disintegration	3	3
Material Discolored	3	3
Delivered as Unsterile Product	3	3
Material Split, Cut or Torn	2	2
Insufficient Information	2	2
Contamination /Decontamination Problem	2	2
Appropriate Term/Code Not Available	2	2
Material Fragmentation	2	2
Packaging Problem	2	2
Failure to Seal	1	1
Display or Visual Feedback Problem	1	1
Loose or Intermittent Connection	1	1
Gel Leak	1	1
Human-Device Interface Problem	1	1
Nonstandard Device	1	5
Fracture	1	1
Contamination of Device Ingredient or Reagent	1	1
Detachment of Device or Device Component	1	1
Device Contamination with Chemical or Other Material	1	1
Misconnection	1	1
Thermal Decomposition of Device	1	1
Difficult to Remove	1	1
Unsealed Device Packaging	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Difficult to Fold, Unfold or Collapse	1	1
Crack	1	1
Peeled/Delaminated	1	1
Failure to Eject	1	1
Difficult to Open or Remove Packaging Material	1	1
Entrapment of Device	1	1
Physical Resistance/Sticking	1	1
Separation Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	211	215
Insufficient Information	19	19
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	8	8
Hypersensitivity/Allergic reaction	4	4
No Known Impact Or Consequence To Patient	4	4
No Consequences Or Impact To Patient	4	4
Foreign Body Sensation in Eye	3	3
Itching Sensation	3	3
Rash	3	3
Erythema	3	3
Skin Tears	3	3
Post Operative Wound Infection	2	2
Burning Sensation	2	2
Foreign Body In Patient	2	2
Hemorrhage/Bleeding	2	2
Full thickness (Third Degree) Burn	2	2
Bruise/Contusion	2	2
Unspecified Infection	1	1
Skin Inflammation/ Irritation	1	1
Edema	1	1
Blister	1	1
Skin Discoloration	1	1
Swelling	1	1
No Patient Involvement	1	1
Pain	1	1
Eye Injury	1	1
Anaphylactic Shock	1	1
Contact Dermatitis	1	1
Device Embedded In Tissue or Plaque	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	3M Healthcare Business	II	Nov-18-2022
2	Aesculap Implant Systems LLC	II	Jul-22-2022
3	Cardinal Health 200, LLC	II	Jul-08-2021
4	Cardinal Health 200, LLC	II	Mar-24-2021
5	Ecolab Inc	II	Feb-22-2021
6	MEDLINE INDUSTRIES, LP - Northfield	II	Mar-14-2025
7	Microtek Medical Inc.	II	Jul-28-2023
8	Microtek Medical Inc.	II	May-12-2022
9	Microtek Medical, Inc.	II	Jun-12-2025