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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device apparatus, suction, patient care
Regulation Description Patient care suction apparatus.
Product CodeDWM
Regulation Number 870.5050
Device Class 2


Premarket Reviews
ManufacturerDecision
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 3
DENVER BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 4
PFM MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 26
Product quality issue 6
Crack 5
Device inoperable 5
Suction issue 5
Disconnection 3
Leak 3
Detachment of device component 2
Decrease in suction 1
User used incorrect product for intended use 1
Fluid leak 1
Material fragmentation 1
Other (for use when an appropriate device code cannot be identified) 1
Component missing 1
Spark 1
Patient-device incompatibility 1
Connection issue 1
Improper flow or infusion 1
Material separation 1
Inadequate training 1
Total Device Problems 67

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0 1 0 0
Class III 0 0 0 0 0 0 0 0 0 0

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

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