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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device cable
Regulation Description External limb prosthetic component.
Product CodeISN
Regulation Number 890.3420
Device Class 1

Device Problems
Break 8
Device Packaging Compromised 7
Delivered as Unsterile Product 6
Component Missing 6
Unsealed Device Packaging 5
Nonstandard device 5
Seal 4
Cable 4
Device Operates Differently Than Expected 4
Incorrect, Inadequate or Imprecise Result or Readings 3
Packaging Problem 3
Positioning Problem 2
Material Integrity Problem 2
Device Contamination with Body Fluid 1
Catheter 1
Device Displays Incorrect Message 1
Contamination / decontamination Problem 1
Material Fragmentation 1
Total Device Problems 64


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