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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search Show TPLC since Back To Search Results
Device apparatus, suction, patient care
Regulation Description Patient care suction apparatus.
Product CodeDWM
Regulation Number 870.5050
Device Class 2


Premarket Reviews
ManufacturerDecision
CAREFUSION
  SUBSTANTIALLY EQUIVALENT 2
ROCKET MEDICAL PLC
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 26
Valve 18
Suction Problem 6
Product Quality Problem 6
Crack 6
Device Inoperable 5
Leak / Splash 4
Disconnection 3
Catheter 2
Detachment Of Device Component 2
Cap 2
Improper Flow or Infusion 1
Material Separation 1
Fluid Leak 1
Connector 1
Material Deformation 1
Device Sensing Problem 1
Material Integrity Problem 1
Material Fragmentation 1
Inadequate or Insufficient Training 1
Off-Label Use 1
Patient-Device Incompatibility 1
Decrease in Suction 1
Component Missing 1
Connection Problem 1
Improper or Incorrect Procedure or Method 1
Total Device Problems 95

Recalls
Manufacturer Recall Class Date Posted
1 Pfm Medical Inc II Dec-12-2014

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