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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter, retention type, balloon
Regulation Description Urological catheter and accessories.
Product CodeEZL
Regulation Number 876.5130
Device Class 2


Premarket Reviews
ManufacturerDecision
AMSINO INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
C. R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 2
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 1
COVALON TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
HOSPIRA INC.
  SUBSTANTIALLY EQUIVALENT 1
JIANGXI YIKANG MEDICAL INSTRUMENT GROUP CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
POIESIS MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
POTRERO MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT - KIT 1
SEEDINGS LIFE SCIENCE VENTURES, LLC
  SUBSTANTIALLY EQUIVALENT 1
TELEFLEX MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
TELEFLEX MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
WELL LEAD MEDICAL CO. LTD
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Deflation Problem 298
Burst Container or Vessel 257
Break 121
Leak / Splash 110
Fluid Leak 58
Difficult to Remove 58
Inflation Problem 40
Material Invagination 37
Mushroomed 33
Material Deformation 32
Inaccurate Flow rate 28
Failure to Infuse 27
Device Dislodged or Dislocated 24
Defective Device 21
Erratic or Intermittent Display 21
Partial Blockage 19
Patient-Device Incompatibility 19
Occlusion Within Device 18
Bent 17
Device Damaged Prior to Use 17
Hole In Material 12
Material Rupture 11
Manufacturing, Packaging or Shipping Problem 11
Device Markings / Labelling Problem 10
Device Operates Differently Than Expected 10
Tear, Rip or Hole in Device Packaging 8
Misassembled 8
Incorrect Measurement 8
Restricted Flow rate 7
Material Protrusion / Extrusion 7
Device Contamination with Chemical or Other Material 7
Entrapment of Device 6
Torn Material 6
Insufficient Information 6
Split 6
Material Split, Cut or Torn 6
Balloon 6
Catheter 5
Use of Device Problem 5
Material Twisted / Bent 5
Migration or Expulsion of Device 5
Material Perforation 5
Positioning Problem 4
Disconnection 4
Unsealed Device Packaging 4
Component Missing 4
Adverse Event Without Identified Device or Use Problem 4
Obstruction of Flow 3
Material Puncture / Hole 3
Difficult to Insert 3
Kinked 3
Short Fill 3
Detachment of Device or device Component 3
Difficult to Open or Remove Packaging Material 2
Blocked Connection 2
Cut In Material 2
Nonstandard device 2
Crack 2
Material Separation 2
Tube 2
Device Packaging Compromised 2
Incorrect Device Or Component Shipped 2
Detachment Of Device Component 2
Unintended Movement 2
Unintended Ejection 2
Inadequate Instructions for Healthcare Professional 2
No Flow 2
Failure to Eject 2
Activation Failure Including Expansion Failures 2
Delivered as Unsterile Product 2
Improper or Incorrect Procedure or Method 2
Material Integrity Problem 2
Defective Component 1
Failure to Advance 1
Calcified 1
Fracture 1
Physical Resistance 1
Wire 1
Cuff 1
Balloon mushroomed 1
Tip 1
Appropriate Term/Code Not Available 1
Physical Property Issue 1
Inadequacy of Device Shape and/or Size 1
Device Contaminated during manufacture or shipping 1
Folded 1
Device Damaged by Another Device 1
Material Too Rigid or Stiff 1
Device Expiration Issue 1
Gel Leak 1
Labelling, Instructions for Use or Training Problem 1
Incorrect, Inadequate or Imprecise Result or Readings 1
Inadequate User Interface 1
Output Problem 1
Packaging Problem 1
Scratched Material 1
Material Distortion 1
Total Device Problems 1516

Recalls
Manufacturer Recall Class Date Posted
1 C.R. Bard, Inc. II Sep-15-2016
2 Coloplast Manufacturing US, LLC II Apr-20-2016
3 Covidien LLC II Mar-21-2016
4 Degania Silicone, Ltd. II Sep-20-2018

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