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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
Regulation Description Manual surgical instrument for general use.
Product CodeKDD
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2021 63 64
2022 12 14
2023 43 43
2024 58 58
2025 33 33
2026 28 28

Device Problems MDRs with this Device Problem Events in those MDRs
Inadequate Lubrication 100 100
Break 14 14
Material Integrity Problem 9 9
Device Damaged by Another Device 6 6
Difficult to Open or Close 6 6
Therapeutic or Diagnostic Output Failure 6 6
Expiration Date Error 5 5
Delivered as Unsterile Product 4 4
Material Fragmentation 4 4
No Apparent Adverse Event 4 4
Loss of or Failure to Bond 3 3
Contamination 3 3
Inaccurate Information 3 3
Defective Device 3 3
Microbial Contamination of Device 3 3
Improper or Incorrect Procedure or Method 3 3
Appropriate Device Problem Term/Code Not Available 3 3
Leak/Splash 2 2
Use of Device Problem 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Contamination /Decontamination Problem 2 2
Fracture 2 2
Packaging Problem 1 1
Protective Measures Problem 1 1
Material Deformation 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Insufficient Device Problem Information 1 1
Device-Device Incompatibility 1 1
Device Handling Problem 1 1
Physical Resistance/Sticking 1 1
Device Markings/Labelling Problem 1 1
Detachment of Device or Device Component 1 1
Component Missing 1 1
Tear, Rip or Hole in Device Packaging 1 1
Obstruction of Flow 1 1
Failure to Cut 1 1
Fluid/Blood Leak 1 1
Flaked 1 1
Filling Problem 1 1
Unsealed Device Packaging 1 1
Peeled/Delaminated 1 1
Off-Label Use 1 1
Entrapment of Device 1 1
Material Disintegration 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 142 142
Failure of Implant 29 29
Fluid Discharge 15 18
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 15 15
Unspecified Infection 14 14
Insufficient Information 13 13
Foreign Body In Patient 10 10
Hemorrhage/Blood Loss/Bleeding 6 6
Inflammation 5 5
Pain 5 5
Wound Dehiscence 5 5
Purulent Discharge 4 4
Fever 4 5
Erythema 3 5
Impaired Healing 2 2
Necrosis 2 2
Post Operative Wound Infection 2 2
Rash 2 2
Breast Discomfort/Pain 2 4
Bacterial Infection 2 2
Chills 1 1
Device Embedded In Tissue or Plaque 1 1
Muscle Weakness/Atrophy 1 1
Local Reaction 1 1
Tissue Breakdown 1 1
Hyporesponsive to stimuli 1 1
Seroma 1 1
Blister 1 1
Swelling/ Edema 1 1
Eye Infections 1 1
Itching Sensation 1 1
Unspecified Gastrointestinal Problem 1 1
Nerve Damage 1 1

Recalls
Manufacturer Recall Class Date Posted
1 ARROW INTERNATIONAL, LLC I Jun-13-2026
2 Allergan Sales, LLC II Apr-29-2024
3 Beaver Visitec International, Inc. II Aug-28-2024
4 Beaver Visitec International, Inc. II Mar-01-2023
5 Biomet, Inc. II Nov-15-2024
6 Bioseal Corporation II May-20-2021
7 DeRoyal Industries Inc II Nov-05-2024
8 DeRoyal Industries Inc II Jul-03-2023
9 MEDLINE INDUSTRIES, LP - Northfield II Apr-17-2025
10 MEDLINE INDUSTRIES, LP - Northfield I Apr-04-2025
11 MEDLINE INDUSTRIES, LP - Northfield II Mar-26-2025
12 MEDLINE INDUSTRIES, LP - Northfield II Dec-30-2024
13 MEDLINE INDUSTRIES, LP - Northfield II Dec-05-2024
14 MEDLINE INDUSTRIES, LP - Northfield II Oct-23-2024
15 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
16 MEDLINE INDUSTRIES, LP - Northfield II Mar-29-2024
17 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
18 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
19 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
20 MEDLINE INDUSTRIES, LP - Northfield II Feb-10-2023
21 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
22 MICROspecialties, Inc. II Jul-11-2024
23 Medical Action Industries, Inc. 306 II Jun-24-2021
24 Medline Industries, LP II Jun-29-2026
25 Medline Industries, LP II Jun-25-2026
26 Medline Industries, LP II Jun-17-2026
27 Medline Industries, LP II May-07-2026
28 Medline Industries, LP II Apr-30-2026
29 Medline Industries, LP II Feb-17-2026
30 Medline Industries, LP II Nov-14-2025
31 Stryker Corporation II Nov-09-2023
32 Synergetics Inc I Jul-11-2024
33 Vortex Surgical Inc. II Feb-04-2026
34 Windstone Medical Packaging, Inc. II Apr-22-2026
35 Windstone Medical Packaging, Inc. I Feb-16-2024
36 Windstone Medical Packaging, Inc. II May-23-2023
37 Windstone Medical Packaging, Inc. II Jan-04-2023
38 Windstone Medical Packaging, Inc. II May-17-2022
39 Windstone Medical Packaging, Inc. II Jun-11-2021
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