TPLC - Total Product Life Cycle

• Device: central venous catheter dressing change kit
• Definition: This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.
• Product Code: PEZ
• Regulation Number: 880.5200
• Device Class: 2

MDR Year	MDR Reports	MDR Events
2019	12	12
2020	1	1
2021	5	5
2022	5	5
2023	6	6

Device Problems	MDRs with this Device Problem	Events in those MDRs
Insufficient Information	11	11
Component Incompatible	3	3
Fitting Problem	1	1
Device Contaminated During Manufacture or Shipping	1	1
Material Split, Cut or Torn	1	1
Material Puncture/Hole	1	1
Patient-Device Incompatibility	1	1
Difficult to Advance	1	1
Defective Device	1	1
Material Integrity Problem	1	1
Contamination	1	1
Contamination /Decontamination Problem	1	1
Component Missing	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Product Quality Problem	1	1
Tear, Rip or Hole in Device Packaging	1	1
Component Misassembled	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Patient Problem/Medical Problem	11	11
Fever	11	11
Insufficient Information	7	7
No Clinical Signs, Symptoms or Conditions	4	4
Local Reaction	3	3
Hypersensitivity/Allergic reaction	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
No Known Impact Or Consequence To Patient	1	1
Dyspnea	1	1
Cough	1	1
Tissue Breakdown	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Medical Action Industries, Inc. 306	II	Oct-19-2021
2	Medical Action Industries, Inc. 306	I	May-12-2021
3	Resource Optimization & Innovation LLC	II	Jun-15-2020