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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device syringe, antistick
Regulation Description Piston syringe.
Product CodeMEG
Regulation Number 880.5860
Device Class 2


Premarket Reviews
ManufacturerDecision
BD
  SUBSTANTIALLY EQUIVALENT 1
BIOTOP TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
EXELINT INTERNATIONAL CO
  SUBSTANTIALLY EQUIVALENT 2
LIFE-SHIELD PRODUCTS, INC
  SUBSTANTIALLY EQUIVALENT 5
MEDICAL DEVICE MANUFACTURER (THAILAND) LTD.
  SUBSTANTIALLY EQUIVALENT 2
MEDLINE
  SUBSTANTIALLY EQUIVALENT 1
MEDSAFE ASA
  SUBSTANTIALLY EQUIVALENT 1
NEW MEDICAL TECHNOLOGY
  SUBSTANTIALLY EQUIVALENT 2
RETRACTABLE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 4
SAFETY SYRINGES, INC.
  SUBSTANTIALLY EQUIVALENT 7
SHANDONG WEIGAO GROUP MEDICAL POLYMER CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1
SMITHS
  SUBSTANTIALLY EQUIVALENT 3
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 2
ULTIMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
WUXI YUSHOU MEDICAL APPLICANCES CO., LTD
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Detachment of device component 21
Shielding failure 16
Use of Device Issue 16
Break 12
Bent 6
Safety interlock(s) inadequate 6
No Known Device Problem 5
Component(s), broken 5
Needle, unsheathed 4
Fail-safe design failure 3
Device or device fragments location unknown 3
Detachment of device or device component 2
Material puncture 2
Unknown (for use when the device problem is not known) 2
Failure to advance 2
Difficult or delayed activation 1
Material separation 1
Slippage of device or device component 1
Migration of device or device component 1
Needle, separation 1
Failure to deploy 1
Disassembly 1
Blockage within device or device component 1
Failure to capture 1
Device operates differently than expected 1
Fail-safe mechanism issue 1
Inappropriate or unexpected reset 1
Locking mechanism failure 1
Patient-device incompatibility 1
Protective measure issue 1
Not Applicable 1
Total Device Problems 121

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 1 0 0 1 1 1 0
Class III 0 0 1 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Becton Dickinson & Company II Jun-21-2013
2 Becton Dickinson & Company III Jan-13-2009
3 Inviro Medical Devices, Inc II Jun-11-2010
4 Smiths Medical ASD, Inc. II Jan-08-2014
5 Terumo Medical Corp II Dec-24-2015

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