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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter, straight
Regulation Description Urological catheter and accessories.
Product CodeEZD
Regulation Number 876.5130
Device Class 2


Premarket Reviews
ManufacturerDecision
ADAPTA MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDLINE
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHAOXING FUQING HEALTH PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Product Quality Problem 379
Patient-Device Incompatibility 136
Adverse Event Without Identified Device or Use Problem 86
Device Damaged Prior to Use 65
Incorrect Measurement 59
Misassembled 53
Inaccurate Flow rate 30
Material Twisted / Bent 24
Difficult to Insert 23
Biocompatibility 15
Insufficient Information 14
Nonstandard device 12
Sharp Edges 11
Difficult to Remove 8
Leak / Splash 8
Partial Blockage 7
Improper or Incorrect Procedure or Method 6
Deformation Due to Compressive Stress 6
Break 5
Inadequate Instructions for Healthcare Professional 5
Use of Device Problem 4
Tear, Rip or Hole in Device Packaging 3
Device Contamination with Chemical or Other Material 3
Improper Chemical Reaction 3
Short Fill 3
Material Separation 2
Fracture 2
Material Fragmentation 2
Flaked 2
Restricted Flow rate 2
Cut In Material 2
Material Too Soft / Flexible 2
Appropriate Term/Code Not Available 1
Expiration Date Error 1
Material Too Rigid or Stiff 1
Migration or Expulsion of Device 1
Off-Label Use 1
Material Puncture / Hole 1
Inadequacy of Device Shape and/or Size 1
Material Perforation 1
Device Issue 1
Manufacturing, Packaging or Shipping Problem 1
Material Deformation 1
Material Protrusion / Extrusion 1
Detachment of Device or device Component 1
Difficult to Open or Remove Packaging Material 1
Total Device Problems 996

Recalls
Manufacturer Recall Class Date Posted
1 C.R. Bard, Inc. II Apr-04-2018

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