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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
2016 5 5
2017 5 5
2018 2 2
2019 12 12
2020 1 1
2021 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 11 11
Device Contamination with Chemical or Other Material 6 6
Packaging Problem 2 2
Component Misassembled 1 1
Material Split, Cut or Torn 1 1
Device Contaminated During Manufacture or Shipping 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Integrity Problem 1 1
Failure To Adhere Or Bond 1 1
Break 1 1
Contamination 1 1
Material Puncture/Hole 1 1
Product Quality Problem 1 1
Component Missing 1 1
Tear, Rip or Hole in Device Packaging 1 1
Defective Device 1 1
Patient-Device Incompatibility 1 1
Contamination /Decontamination Problem 1 1
Device Operates Differently Than Expected 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Fever 11 11
Patient Problem/Medical Problem 11 11
No Patient Involvement 5 5
No Known Impact Or Consequence To Patient 4 4
Insufficient Information 4 4
No Clinical Signs, Symptoms or Conditions 2 2
No Code Available 1 1
Rash 1 1
Skin Irritation 1 1
No Consequences Or Impact To Patient 1 1
Reaction 1 1
Underdose 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
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