TPLC - Total Product Life Cycle

show TPLC since

Device	kit, surgical instrument, disposable
Product Code	KDD
Regulation Number	878.4800
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Inadequate Lubrication	46	46
Adverse Event Without Identified Device or Use Problem	43	43
Break	19	19
Contamination /Decontamination Problem	12	12
Device Damaged by Another Device	10	10
Material Integrity Problem	9	9
Output Problem	8	8
Appropriate Term/Code Not Available	7	7
Expiration Date Error	5	5
Fluid/Blood Leak	5	5
Contamination	4	4
Electrical /Electronic Property Problem	4	4
Leak/Splash	4	4
Device Contamination with Chemical or Other Material	4	4
Patient-Device Incompatibility	3	3
Delivered as Unsterile Product	3	3
Loss of or Failure to Bond	3	3
Inaccurate Information	3	3
Insufficient Information	2	2
Packaging Problem	2	2
Material Fragmentation	2	2
Product Quality Problem	2	2
Manufacturing, Packaging or Shipping Problem	2	2
Detachment of Device or Device Component	2	2
Device Markings/Labelling Problem	2	2
Arcing	2	2
Improper or Incorrect Procedure or Method	2	2
Microbial Contamination of Device	2	2
Component Missing	1	1
Device Contamination with Body Fluid	1	1
Tear, Rip or Hole in Device Packaging	1	1
Obstruction of Flow	1	1
Suction Problem	1	1
Sparking	1	1
Device-Device Incompatibility	1	1
Device Contaminated During Manufacture or Shipping	1	1
Material Separation	1	1
Use of Device Problem	1	1
Mechanical Problem	1	1
Nonstandard Device	1	1
Peeled/Delaminated	1	1
Failure to Power Up	1	1
Off-Label Use	1	1
Material Puncture/Hole	1	1
Fracture	1	1
Entrapment of Device	1	1
Unintended Ejection	1	1
Crack	1	1
Power Problem	1	1
Protective Measures Problem	1	1
Ejection Problem	1	1
Mechanical Jam	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	74	74
Unspecified Infection	24	24
Fluid Discharge	23	23
Failure of Implant	19	19
No Known Impact Or Consequence To Patient	12	12
Pain	12	12
No Consequences Or Impact To Patient	11	11
Inflammation	9	9
Wound Dehiscence	8	8
Purulent Discharge	8	8
Insufficient Information	7	7
Foreign Body In Patient	6	6
Erythema	5	5
Fever	5	5
Impaired Healing	4	4
No Code Available	4	4
Post Operative Wound Infection	4	4
No Patient Involvement	4	4
Device Embedded In Tissue or Plaque	3	3
Bacterial Infection	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Breast Discomfort/Pain	2	2
Necrosis	2	2
Rash	2	2
Seroma	2	2
Not Applicable	2	2
Discharge	2	2
Chills	2	2
Discomfort	1	1
Tissue Breakdown	1	1
Decreased Sensitivity	1	1
Eye Infections	1	1
Unspecified Gastrointestinal Problem	1	1
Sweating	1	1
Swelling	1	1
Local Reaction	1	1
Nerve Damage	1	1
Cellulitis	1	1
Edema	1	1
Itching Sensation	1	1
Muscle Weakness	1	1
Blister	1	1
Swelling/ Edema	1	1

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