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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device drape, surgical
Regulation Description Surgical drape and drape accessories.
Product CodeKKX
Regulation Number 878.4370
Device Class 2


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 1
AVERY DENNISON BELGIE BVBA
  SUBSTANTIALLY EQUIVALENT 1
AVERY DENNISON MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
CONTROLRAD, INC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 16 16
2021 41 41
2022 19 19
2023 32 32
2024 19 19
2025 15 15

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 21 21
Material Split, Cut or Torn 13 13
Material Puncture/Hole 11 11
Human-Device Interface Problem 11 11
Contamination /Decontamination Problem 7 7
Manufacturing, Packaging or Shipping Problem 6 6
Break 5 5
Patient Device Interaction Problem 4 4
Detachment of Device or Device Component 4 4
Appropriate Term/Code Not Available 4 4
Device Damaged Prior to Use 3 3
Insufficient Information 3 3
Contamination 3 3
Improper or Incorrect Procedure or Method 3 3
Output Problem 2 2
Use of Device Problem 2 2
Packaging Problem 2 2
Device Contamination with Chemical or Other Material 2 2
Fluid/Blood Leak 2 2
Device Contaminated During Manufacture or Shipping 1 1
Entrapment of Device 1 1
Physical Resistance/Sticking 1 1
Incomplete or Inadequate Connection 1 1
Material Disintegration 1 1
Unsealed Device Packaging 1 1
Material Fragmentation 1 1
Difficult to Insert 1 1
Material Discolored 1 1
Device Difficult to Setup or Prepare 1 1
Component Missing 1 1
Blocked Connection 1 1
Material Deformation 1 1
Product Quality Problem 1 1
Material Separation 1 1
Tear, Rip or Hole in Device Packaging 1 1
No Apparent Adverse Event 1 1
Component Misassembled 1 1
Nonstandard Device 1 1
Component Incompatible 1 1
Display or Visual Feedback Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 64 64
Skin Tears 32 32
Pain 16 16
Erythema 15 15
Blister 13 13
Insufficient Information 13 13
Skin Inflammation/ Irritation 9 9
Skin Burning Sensation 8 8
No Known Impact Or Consequence To Patient 7 7
Burning Sensation 7 7
Swelling/ Edema 7 7
Foreign Body In Patient 4 4
Burn(s) 3 3
Exposure to Body Fluids 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Unspecified Infection 2 2
Wound Dehiscence 2 2
Laceration(s) 2 2
No Consequences Or Impact To Patient 2 2
Hemorrhage/Bleeding 2 2
Hypersensitivity/Allergic reaction 1 1
Failure of Implant 1 1
Local Reaction 1 1
Swelling 1 1
Discomfort 1 1
Missing Value Reason 1 1
Bacterial Infection 1 1
Full thickness (Third Degree) Burn 1 1
Device Embedded In Tissue or Plaque 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Arrow International Inc II Feb-14-2020
2 MEDLINE INDUSTRIES, LP - Northfield II Apr-17-2025
3 MEDLINE INDUSTRIES, LP - Northfield II Oct-23-2024
4 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
5 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
6 MEDLINE INDUSTRIES, LP - Northfield II Feb-10-2023
7 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
8 O&M HALYARD, INC. II Jan-17-2025
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