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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 4
COMPACTCATH INC
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHAOXING FUQING HEALTH PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
WELL LEAD MEDICAL CO. LTD
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Product Quality Problem 308
Patient-Device Incompatibility 106
Adverse Event Without Identified Device or Use Problem 70
Device Damaged Prior to Use 46
Incorrect Measurement 38
Misassembled 31
Inaccurate Flow rate 24
Material Twisted / Bent 22
Difficult to Insert 15
Nonstandard device 11
Partial Blockage 10
Insufficient Information 10
Difficult to Remove 8
Leak / Splash 6
Improper or Incorrect Procedure or Method 6
Deformation Due to Compressive Stress 5
Inadequate Instructions for Healthcare Professional 5
Device Contamination with Chemical or Other Material 4
Break 4
Use of Device Problem 3
Tear, Rip or Hole in Device Packaging 3
Catheter 2
Material Separation 2
Cut In Material 2
Restricted Flow rate 2
Fracture 2
Sharp Edges 2
Material Protrusion / Extrusion 1
Appropriate Term/Code Not Available 1
Expiration Date Error 1
Off-Label Use 1
Short Fill 1
Detachment of Device or device Component 1
Difficult to Open or Remove Packaging Material 1
Manufacturing, Packaging or Shipping Problem 1
Material Too Soft / Flexible 1
Material Deformation 1
Device Issue 1
Migration or Expulsion of Device 1
Material Puncture / Hole 1
Total Device Problems 760

Recalls
Manufacturer Recall Class Date Posted
1 C.R. Bard, Inc. II Apr-04-2018
2 Cure Medical LLC II Dec-16-2014

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