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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device needle, aspiration and injection, disposable
Regulation Description Manual surgical instrument for general use.
Product CodeGAA
Regulation Number 878.4800
Device Class 1

Device Problems
Device Contamination with Chemical or Other Material 65
Break 64
Adverse Event Without Identified Device or Use Problem 27
Leak/Splash 19
Fracture 17
Packaging Problem 10
Insufficient Information 7
Device Markings/Labelling Problem 7
Contamination /Decontamination Problem 6
Detachment of Device or Device Component 6
Delivered as Unsterile Product 6
Use of Device Problem 4
Complete Blockage 4
Signal Artifact/Noise 4
Contamination 4
Device Operates Differently Than Expected 4
Material Twisted/Bent 3
Material Fragmentation 3
Migration or Expulsion of Device 2
Improper or Incorrect Procedure or Method 2
Difficult to Advance 2
Short Fill 2
Delivery System Failure 1
Material Deformation 1
Tip 1
Device Handling Problem 1
Suction Failure 1
Premature Separation 1
Illegible Information 1
Device Damaged Prior to Use 1
Solder Joint Fracture 1
Failure to Deliver 1
Failure to Obtain Sample 1
Product Quality Problem 1
Difficult to Remove 1
Material Separation 1
Partial Blockage 1
Detachment Of Device Component 1
Total Device Problems 284

Recalls
Manufacturer Recall Class Date Posted
1 Cadence Inc. II Aug-10-2015
2 Vitreq Bv II Jan-24-2020

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