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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
AVERY DENNISON BELGIE BVBA
  SUBSTANTIALLY EQUIVALENT 1
CONTROLRAD, INC
  SUBSTANTIALLY EQUIVALENT 1
COVALON TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 30 30
2018 32 32
2019 41 41
2020 16 16
2021 41 41

Device Problems MDRs with this Device Problem Events in those MDRs
Material Puncture/Hole 27 27
Adverse Event Without Identified Device or Use Problem 27 27
Material Split, Cut or Torn 13 13
Hole In Material 13 13
Contamination /Decontamination Problem 10 10
Device Contamination with Chemical or Other Material 8 8
Break 7 7
Contamination 4 4
Detachment of Device or Device Component 4 4
Appropriate Term/Code Not Available 4 4
Torn Material 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Device Operates Differently Than Expected 3 3
Device Contamination with Body Fluid 3 3
Delivered as Unsterile Product 3 3
Product Quality Problem 2 2
Material Rupture 2 2
Fluid Leak 2 2
Tear, Rip or Hole in Device Packaging 2 2
Material Perforation 2 2
Leak/Splash 2 2
Peeled/Delaminated 2 2
Improper or Incorrect Procedure or Method 2 2
Connection Problem 2 2
Defective Device 2 2
Material Integrity Problem 2 2
Packaging Problem 2 2
Insufficient Information 2 2
No Apparent Adverse Event 1 1
Material Protrusion/Extrusion 1 1
No Flow 1 1
Device Contaminated During Manufacture or Shipping 1 1
Output Problem 1 1
Device Displays Incorrect Message 1 1
Patient-Device Incompatibility 1 1
Device Packaging Compromised 1 1
Difficult to Open or Remove Packaging Material 1 1
Device Markings/Labelling Problem 1 1
Fitting Problem 1 1
Device Damaged Prior to Use 1 1
Split 1 1
Material Fragmentation 1 1
Failure To Adhere Or Bond 1 1
Loss of or Failure to Bond 1 1
Material Discolored 1 1
Material Disintegration 1 1
Flaked 1 1
Material Separation 1 1
Unsealed Device Packaging 1 1
Difficult to Insert 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 76 76
No Clinical Signs, Symptoms or Conditions 24 24
Skin Tears 12 12
Blister 11 11
Pain 11 11
Erythema 9 9
Skin Inflammation/ Irritation 9 9
Skin Burning Sensation 8 8
No Information 7 7
No Consequences Or Impact To Patient 6 6
Insufficient Information 6 6
Injury 4 4
Rash 4 4
Burn(s) 4 4
Ulceration 4 4
Skin Irritation 3 3
Foreign Body In Patient 3 3
No Patient Involvement 2 2
Reaction 2 2
Discomfort 2 2
Local Reaction 2 2
Hemorrhage/Bleeding 2 2
Irritation 2 2
Itching Sensation 1 1
Vessel Or Plaque, Device Embedded In 1 1
Bacterial Infection 1 1
Hypothermia 1 1
Hypoxia 1 1
Scarring 1 1
Increased Sensitivity 1 1
Swelling 1 1
Needle Stick/Puncture 1 1
No Code Available 1 1
Missing Value Reason 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Arrow International Inc II Feb-14-2020
2 Arrow International Inc II May-30-2018
3 Cardinal Health 200, LLC II Jul-07-2017
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