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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device kit, surgical instrument, disposable
Product CodeKDD
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2015 54 54
2016 31 31
2017 12 12
2018 17 17
2019 22 22
2020 44 44
2021 63 63
2022 12 12
2023 43 43
2024 27 27

Device Problems MDRs with this Device Problem Events in those MDRs
Inadequate Lubrication 46 46
Adverse Event Without Identified Device or Use Problem 45 45
Delivered as Unsterile Product 30 30
Break 30 30
Material Integrity Problem 16 16
Device Damaged by Another Device 15 15
Contamination /Decontamination Problem 12 12
Device Contamination with Chemical or Other Material 10 10
Fluid/Blood Leak 10 10
Output Problem 8 8
Leak/Splash 8 8
Appropriate Term/Code Not Available 8 8
Device Operates Differently Than Expected 7 7
Expiration Date Error 5 5
Patient-Device Incompatibility 5 5
Failure To Adhere Or Bond 5 5
Electrical /Electronic Property Problem 5 5
Material Frayed 5 5
Device Contaminated During Manufacture or Shipping 5 5
Detachment of Device or Device Component 5 5
Mechanical Problem 5 5
Insufficient Information 4 4
Material Fragmentation 4 4
Physical Property Issue 4 4
Tear, Rip or Hole in Device Packaging 4 4
Contamination 4 4
Product Quality Problem 3 3
Fracture 3 3
Component Missing 3 3
Loss of or Failure to Bond 3 3
Hole In Material 3 3
Inaccurate Information 3 3
Mechanical Jam 3 3
Arcing 3 3
Packaging Problem 3 3
Device Markings/Labelling Problem 3 3
Manufacturing, Packaging or Shipping Problem 2 2
Microbial Contamination of Device 2 2
Material Perforation 2 2
Crack 2 2
Detachment Of Device Component 2 2
Air Leak 2 2
Device Packaging Compromised 2 2
Bent 2 2
Improper or Incorrect Procedure or Method 2 2
Device Contamination with Body Fluid 1 1
Power Problem 1 1
Defective Component 1 1
Material Discolored 1 1
Sparking 1 1
Suction Problem 1 1
Unintended Ejection 1 1
Activation, Positioning or Separation Problem 1 1
Device Difficult to Setup or Prepare 1 1
Obstruction of Flow 1 1
Material Puncture/Hole 1 1
Shipping Damage or Problem 1 1
Use of Device Problem 1 1
Failure to Cut 1 1
Degraded 1 1
Positioning Failure 1 1
Failure to Power Up 1 1
Off-Label Use 1 1
Human Factors Issue 1 1
Protective Measures Problem 1 1
Device Issue 1 1
Unsealed Device Packaging 1 1
Out-Of-Box Failure 1 1
Material Separation 1 1
Device-Device Incompatibility 1 1
Peeled/Delaminated 1 1
Material Deformation 1 1
Nonstandard Device 1 1
Shelf Life Exceeded 1 1
Ejection Problem 1 1
Flaked 1 1
Entrapment of Device 1 1
Dull, Blunt 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 74 74
No Known Impact Or Consequence To Patient 68 68
No Consequences Or Impact To Patient 35 35
Unspecified Infection 26 26
Fluid Discharge 25 25
Failure of Implant 19 19
No Patient Involvement 14 14
Pain 14 14
Inflammation 10 10
Device Embedded In Tissue or Plaque 10 10
Purulent Discharge 9 9
Wound Dehiscence 8 8
Foreign Body In Patient 8 8
No Code Available 8 8
Insufficient Information 7 7
No Information 5 5
Post Operative Wound Infection 5 5
Bacterial Infection 5 5
Erythema 5 5
Fever 5 5
Impaired Healing 4 4
Discomfort 3 3
Rash 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Breast Discomfort/Pain 2 2
Necrosis 2 2
Itching Sensation 2 2
Discharge 2 2
Seroma 2 2
Swelling 2 2
Chills 2 2
Not Applicable 2 2
Skin Tears 1 1
Abdominal Distention 1 1
Tissue Breakdown 1 1
Decreased Sensitivity 1 1
Peritonitis 1 1
Sweating 1 1
Muscle Weakness 1 1
Cellulitis 1 1
Edema 1 1
Nerve Damage 1 1
Local Reaction 1 1
Scar Tissue 1 1
Blister 1 1
Swelling/ Edema 1 1
Eye Infections 1 1
Unspecified Gastrointestinal Problem 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Arrow International Inc II May-30-2018
2 Arrow International Inc II Apr-03-2018
3 Beaver Visitec International, Inc. II Mar-01-2023
4 Bioseal Corporation II May-20-2021
5 Bioseal Corporation II Nov-09-2017
6 DeRoyal Industries Inc II Jul-03-2023
7 DeRoyal Industries Inc II May-11-2020
8 MEDLINE INDUSTRIES, LP - Northfield II Mar-29-2024
9 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
10 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
11 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
12 MEDLINE INDUSTRIES, LP - Northfield II Feb-10-2023
13 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
14 Medical Action Industries, Inc. 306 II Jun-24-2021
15 Medical Action Industries, Inc. 306 II Jan-06-2020
16 ROi Consolidated Service Center (CSC) II Aug-08-2019
17 Stryker Corporation II Nov-09-2023
18 Stryker Corporation II Mar-02-2018
19 Utah Medical Products, Inc II Nov-06-2015
20 Windstone Medical Packaging, Inc. I Feb-16-2024
21 Windstone Medical Packaging, Inc. II May-23-2023
22 Windstone Medical Packaging, Inc. II Jan-04-2023
23 Windstone Medical Packaging, Inc. II May-17-2022
24 Windstone Medical Packaging, Inc. II Jun-11-2021
25 Windstone Medical Packaging, Inc. II Dec-04-2015
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