TPLC - Total Product Life Cycle

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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
Adverse Event Without Identified Device or Use Problem	44	44
Break	21	21
Device Damaged by Another Device	14	14
Inadequate Lubrication	13	13
Contamination /Decontamination Problem	12	12
Output Problem	8	8
Material Integrity Problem	8	8
Appropriate Term/Code Not Available	7	7
Device Contamination with Chemical or Other Material	6	6
Fluid/Blood Leak	6	6
Leak/Splash	6	6
Electrical /Electronic Property Problem	5	5
Detachment of Device or Device Component	5	5
Expiration Date Error	5	5
Contamination	4	4
Insufficient Information	4	4
Inaccurate Information	3	3
Patient-Device Incompatibility	3	3
Mechanical Problem	3	3
Loss of or Failure to Bond	3	3
Delivered as Unsterile Product	3	3
Arcing	3	3
Device Markings/Labelling Problem	2	2
Product Quality Problem	2	2
Improper or Incorrect Procedure or Method	2	2
Microbial Contamination of Device	2	2
Material Fragmentation	2	2
Manufacturing, Packaging or Shipping Problem	2	2
Packaging Problem	2	2
Power Problem	1	1
Protective Measures Problem	1	1
Mechanical Jam	1	1
Ejection 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
Crack	1	1
Material Discolored	1	1
Unintended Ejection	1	1
Fracture	1	1
Component Missing	1	1
Device Contamination with Body Fluid	1	1
Obstruction of Flow	1	1
Suction Problem	1	1
Material Separation	1	1
Use of Device Problem	1	1
Sparking	1	1
Device Contaminated During Manufacture or Shipping	1	1
Device-Device Incompatibility	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	49	49
Unspecified Infection	25	25
Fluid Discharge	24	24
No Known Impact Or Consequence To Patient	22	22
No Consequences Or Impact To Patient	12	12
Pain	12	12
Inflammation	10	10
Purulent Discharge	9	9
Wound Dehiscence	8	8
No Patient Involvement	6	6
Post Operative Wound Infection	5	5
Foreign Body In Patient	5	5
Erythema	5	5
Fever	5	5
Failure of Implant	5	5
Insufficient Information	5	5
Bacterial Infection	4	4
Device Embedded In Tissue or Plaque	4	4
No Code Available	4	4
Impaired Healing	4	4
Rash	3	3
Seroma	2	2
Necrosis	2	2
Itching Sensation	2	2
Discharge	2	2
Chills	2	2
Breast Discomfort/Pain	2	2
Not Applicable	2	2
Blister	1	1
Swelling/ Edema	1	1
Eye Infections	1	1
Unspecified Gastrointestinal Problem	1	1
Tissue Breakdown	1	1
Decreased Sensitivity	1	1
Discomfort	1	1
Sweating	1	1
Muscle Weakness	1	1
Cellulitis	1	1
Edema	1	1
Nerve Damage	1	1
Swelling	1	1
Local Reaction	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	DeRoyal Industries Inc	II	Jul-03-2023
6	DeRoyal Industries Inc	II	May-11-2020
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	Stryker Corporation	II	Mar-02-2018
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