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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device drape, surgical
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
2019 41 41
2020 16 16
2021 41 41
2022 19 19
2023 32 32
2024 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
Material Puncture/Hole 26 26
Adverse Event Without Identified Device or Use Problem 25 25
Material Split, Cut or Torn 13 13
Human-Device Interface Problem 11 11
Contamination /Decontamination Problem 9 9
Break 6 6
Detachment of Device or Device Component 6 6
Manufacturing, Packaging or Shipping Problem 5 5
Contamination 5 5
Appropriate Term/Code Not Available 4 4
Patient Device Interaction Problem 4 4
Improper or Incorrect Procedure or Method 3 3
Device Contamination with Chemical or Other Material 3 3
Device Damaged Prior to Use 3 3
Insufficient Information 3 3
Fluid/Blood Leak 2 2
Tear, Rip or Hole in Device Packaging 2 2
Product Quality Problem 2 2
Packaging Problem 2 2
Use of Device Problem 2 2
Output Problem 2 2
Device Contaminated During Manufacture or Shipping 2 2
Material Discolored 1 1
Device Difficult to Setup or Prepare 1 1
Difficult to Insert 1 1
Component Missing 1 1
Material Perforation 1 1
Blocked Connection 1 1
Material Fragmentation 1 1
Delivered as Unsterile Product 1 1
Material Integrity Problem 1 1
Defective Device 1 1
Material Separation 1 1
Unsealed Device Packaging 1 1
Material Disintegration 1 1
Incomplete or Inadequate Connection 1 1
No Apparent Adverse Event 1 1
Component Misassembled 1 1
Nonstandard Device 1 1
Connection Problem 1 1
Entrapment of Device 1 1
Component Incompatible 1 1
Display or Visual Feedback Problem 1 1
No Flow 1 1
Leak/Splash 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 48 48
No Known Impact Or Consequence To Patient 40 40
Skin Tears 31 31
Pain 19 19
Erythema 16 16
Blister 13 13
Insufficient Information 11 11
Skin Inflammation/ Irritation 9 9
Skin Burning Sensation 8 8
Burning Sensation 7 7
Swelling/ Edema 7 7
Injury 4 4
Foreign Body In Patient 4 4
Burn(s) 3 3
Exposure to Body Fluids 3 3
No Consequences Or Impact To Patient 3 3
Unspecified Infection 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Wound Dehiscence 2 2
Laceration(s) 2 2
Hemorrhage/Bleeding 2 2
Vessel Or Plaque, Device Embedded In 1 1
Hypersensitivity/Allergic reaction 1 1
Skin Irritation 1 1
No Information 1 1
Local Reaction 1 1
Scarring 1 1
Swelling 1 1
Discomfort 1 1
No Patient Involvement 1 1
Missing Value Reason 1 1
Bacterial Infection 1 1
Increased Sensitivity 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 Sep-06-2024
3 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
4 MEDLINE INDUSTRIES, LP - Northfield II Feb-10-2023
5 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
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