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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device central venous catheter dressing change kit
Regulation Description Intravascular catheter.
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 CodePEZ
Regulation Number 880.5200
Device Class 2

MDR Year MDR Reports MDR Events
2021 5 5
2022 5 5
2023 6 6
2025 3 3
2026 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Component Incompatible 3 3
Component Missing 2 2
Failure to Advance 2 2
Backflow 1 1
Break 1 1
Contamination 1 1
Fluid/Blood Leak 1 1
Product Quality Problem 1 1
Fitting Problem 1 1
Tear, Rip or Hole in Device Packaging 1 1
Device Contaminated During Manufacture or Shipping 1 1
Moisture or Humidity Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Appropriate Term/Code Not Available 1 1
Component Misassembled 1 1
Material Split, Cut or Torn 1 1
Defective Device 1 1
Patient-Device Incompatibility 1 1
Contamination /Decontamination Problem 1 1
Difficult to Advance 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7 7
Insufficient Information 7 7
Local Reaction 3 3
Hypersensitivity/Allergic reaction 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Chemical Exposure 1 1
Burn(s) 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
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