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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device set, administration, for peritoneal dialysis, disposable
Regulation Description Peritoneal dialysis system and accessories.
Product CodeKDJ
Regulation Number 876.5630
Device Class 2


Premarket Reviews
ManufacturerDecision
BAXTER HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 2
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 3
BAXTER HEALTHCARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
FRESENIUS MEDICAL CARE NORTH AMERICA
  SUBSTANTIALLY EQUIVALENT 3
PURACATH MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Adverse Event Without Identified Device or Use Problem 13187
Improper or Incorrect Procedure or Method 2912
Fluid Leak 1413
Absorber 1385
Cap 1225
Detachment of Device or device Component 878
Crack 840
Connector 778
Disconnection 737
Product Quality Problem 474
Clamp 378
Tube 355
Loose or Intermittent Connection 338
Housing 310
Break 294
Unsealed Device Packaging 169
Connection Problem 164
Device Contamination with Chemical or Other Material 155
Locking Sleeve 122
Packaging Problem 98
Component Missing 90
Misassembled 84
Fitting Problem 80
Foil 78
Leak / Splash 74
Hole In Material 67
Detachment Of Device Component 55
Seal 46
Device Displays Incorrect Message 46
Tear, Rip or Hole in Device Packaging 45
Device Operates Differently Than Expected 42
Adapter (Adaptor) 36
Mechanical Problem 34
Material Puncture / Hole 29
Incomplete or Inadequate Connection 25
Failure to Disconnect 23
Bags 23
Improper Flow or Infusion 19
Material Split, Cut or Torn 19
Device Packaging Compromised 18
Material Separation 17
Cut In Material 16
Insufficient Information 13
Delivered as Unsterile Product 12
Misconnection 11
No Flow 10
Material Deformation 10
Material Integrity Problem 10
Y-Piece Connector 9
Shield 7
Cassette 6
Material Perforation 5
Spacer 5
Radiation Underexposure 5
Port 5
Material Rupture 4
Protective Measures Problem 4
Label 3
Degraded 3
Separation Failure 3
Valve 3
Kinked 3
Contamination During Use 3
Catheter 3
Use of Device Problem 3
Free or Unrestricted Flow 3
Partial Blockage 2
Defective Component 2
Labelling, Instructions for Use or Training Problem 2
Device Markings / Labelling Problem 2
Fracture 2
Expiration Date Error 2
Infusion or Flow Problem 1
Difficult to Open or Close 1
Therapy Delivered to Incorrect Body Area 1
Noise, Audible 1
Obstruction of Flow 1
Scratched Material 1
Suction Problem 1
Expulsion 1
Device Reprocessing Problem 1
Failure to Prime 1
Ring 1
Microbial Contamination of Device 1
Overlay 1
Overfill 1
Luer Valve 1
Device Handling Problem 1
Component Falling 1
Valve, Flow 1
Total Device Problems 27351

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corp. II Oct-30-2015
2 Baxter Healthcare Corp. II Aug-27-2015
3 Baxter Healthcare Corporation II Jun-02-2017

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