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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device syringe, piston
Regulation Description Piston syringe.
Product CodeFMF
Regulation Number 880.5860
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 2
ABCO DEALERS, INC.
  SUBSTANTIALLY EQUIVALENT 7
ADVANCE MEDICAL DESIGNS, INC.
  SUBSTANTIALLY EQUIVALENT 2
ALCON
  SUBSTANTIALLY EQUIVALENT 1
ANHUI KANGDA MEDICAL PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ARROW INTL., INC.
  SUBSTANTIALLY EQUIVALENT 1
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 3
ARTSANA S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
AVID MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
B. BRAUN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 4
BAXA CORP.
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 6
BAYLIS MEDICAL CO., INC.
  SUBSTANTIALLY EQUIVALENT 1
BD
  SUBSTANTIALLY EQUIVALENT 9
BIO-MED
  SUBSTANTIALLY EQUIVALENT 1
BIOMET
  SUBSTANTIALLY EQUIVALENT 5
BUSSE HOSPITAL DISPOSABLES, INC.
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 2
CARDINAL HEALTH
  SUBSTANTIALLY EQUIVALENT 1
CONFLUENT SURGICAL,INC
  SUBSTANTIALLY EQUIVALENT 6
CONMED
  SUBSTANTIALLY EQUIVALENT 1
CORDIS CORP.
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 1
DAEJIN TECH MEDICAL MANUFACTURING CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DISETRONIC MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
DMC MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
DRAGON HEART MEDICAL DEVICES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ELI LILLY AND CO.
  SUBSTANTIALLY EQUIVALENT 4
ETHICON
  SUBSTANTIALLY EQUIVALENT - KIT 1
FEEL TECH
  SUBSTANTIALLY EQUIVALENT 1
GAINOR MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
GUIDANT CORP
  SUBSTANTIALLY EQUIVALENT 1
HARVEST
  SUBSTANTIALLY EQUIVALENT 2
HASELMEIER GMBH
  SUBSTANTIALLY EQUIVALENT 2
HENKE SASS WOLF
  SUBSTANTIALLY EQUIVALENT 1
HOSPIRA INC.
  SUBSTANTIALLY EQUIVALENT 1
ICU MEDICAL SALES, INC.
  SUBSTANTIALLY EQUIVALENT 4
INNOVATIVE MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
INTERPORE CROSS
  SUBSTANTIALLY EQUIVALENT 1
ISOTIS ORTHOBIOLOGICS, INC
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU SHENLI MEDICAL PRODUCTION FACTORY
  SUBSTANTIALLY EQUIVALENT 1
JMS
  SUBSTANTIALLY EQUIVALENT 3
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - KIT 1
KENDALL
  SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS 1
  SUBSTANTIALLY EQUIVALENT 20
MANAN MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDEGEN
  SUBSTANTIALLY EQUIVALENT 1
MEDEX
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 4
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 6
MICRO THERAPEUTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MICROMEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 4
MIDMARK CORP.
  SUBSTANTIALLY EQUIVALENT 1
NAVILYST MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
NIPRO CORP
  SUBSTANTIALLY EQUIVALENT 7
NISSHO CORP
  SUBSTANTIALLY EQUIVALENT 1
NOVO NORDISK
  SUBSTANTIALLY EQUIVALENT 3
OMRIX BIOPHARMACEUTICALS LTD.
  SUBSTANTIALLY EQUIVALENT 2
ORTHOS LIMITED
  SUBSTANTIALLY EQUIVALENT 1
ORTHOVITA
  SUBSTANTIALLY EQUIVALENT 4
OSTEOBIOLOGICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
OWEN MUMFORD
  SUBSTANTIALLY EQUIVALENT 1
PALCO LABS, INC
  SUBSTANTIALLY EQUIVALENT 1
PALL CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
PINYONS MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 3
PORTEX, INC.
  SUBSTANTIALLY EQUIVALENT 1
RETRACTABLE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
RHYTHMLINK INTERNATIONAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
SAFETY 1ST
  SUBSTANTIALLY EQUIVALENT 1
SAFETY SYRINGES, INC.
  SUBSTANTIALLY EQUIVALENT 3
SHANDONG WEIGAO GROUP MEDICAL POLYMER CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI DOUBLE DOVE INDUSTRIAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHIN CHANG MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHINA CORP.
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 2
SPAN-AMERICA MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
  1.  K854255  SPAN / AID SYRINGE
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 2
SURGITEK
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES
  SUBSTANTIALLY EQUIVALENT 1
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 13
THE UNIVERSITY OF CHICAGO
  SUBSTANTIALLY EQUIVALENT 1
THERMOGENESIS CORP.
  SUBSTANTIALLY EQUIVALENT 2
TRIBOFILM RESEARCH, INC.
  SUBSTANTIALLY EQUIVALENT 1
TRINITY
  SUBSTANTIALLY EQUIVALENT - KIT 1
TYCO HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1
ULTIMED, INC.
  SUBSTANTIALLY EQUIVALENT 3
VASCULAR SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 2
VLV ASSOCIATES, INC.
  SUBSTANTIALLY EQUIVALENT 1
WELMED INC.
  SUBSTANTIALLY EQUIVALENT 1
WENZHOU WUZHOU GROUP CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
WRIGHT MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 3
WUXI YUSHOU MEDICAL APPLICANCES CO., LTD
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Component(s), broken 140
Detachment of device component 81
Break 79
Shielding failure 36
Fluid leak 32
No Information 31
Device operates differently than expected 27
Needle, separation 23
Syringe, defective 21
Foreign material present in device 18
Delivered as unsterile product 16
No Known Device Problem 13
Leak 12
Disassembly 10
Use of Device Issue 10
Failure to advance 10
Crack 9
Detachment of device or device component 8
Failure to deliver 7
Material puncture 7
Unknown (for use when the device problem is not known) 6
Disconnection 6
No flow 6
Foreign material 4
Component missing 4
Product quality issue 4
Slippage of device or device component 3
Sticking 3
Improper or incorrect procedure or method 3
Device inoperable 3
Kinked 3
Infusion or flow issue 3
Packaging issue 3
Protective measure issue 2
Not Applicable 2
Mechanical jam 2
Material deformation 2
Device markings issue 2
Dislodged or dislocated 2
User used incorrect product for intended use 2
Mechanical issue 2
Material fragmentation 2
Device expiration issue 2
No display or display failure 2
Failure to deploy 2
Burst 2
Material separation 2
Insufficient flow or underinfusion 2
Other (for use when an appropriate device code cannot be identified) 2
Difficult to remove 2
Retraction problem 2
Inaccurate delivery 2
Difficult or delayed activation 2
Defective item 2
Tear, rip or hole in device packaging 2
Incorrect or inadequate test results 1
High test results 1
Failure to align 1
Malposition of device 1
Aspiration issue 1
Disinfection or Sterilization Issue at User Location 1
Device Issue 1
Defective component 1
Stopcock valve, failure of 1
Out-of-box failure 1
Device contamination with blood or blood product 1
Blood pooling 1
Material rupture 1
Device, or device fragments remain in patient 1
Inadequate storage 1
Spillage, accidental 1
Volume accuracy issue 1
Tip breakage 1
Calibration error 1
Device clogged 1
Component incompatible 1
Connection error 1
Measurements, inaccurate 1
Air leak 1
Entrapment of device or device component 1
Dislodged 1
Filling problem 1
Loose or intermittent connection 1
Loose 1
Hole in material 1
Excess flow or overinfusion 1
Difficult to insert 1
Inadequate instructions for healthcare professional 1
Moisture damage 1
Particulates 1
Failure to prime 1
Filtration issue 1
Material Protrusion 1
Measurement system incompatibility 1
Naturally worn 1
No code available 1
Device handling issue 1
Total Device Problems 727

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 1 0 0 0 0 0
Class II 4 5 8 4 1 3 1 2 4 1
Class III 1 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Bioscience II Nov-24-2007
2 Baxter Corporation Englewood II Jan-30-2016
3 Baxter Corporation Englewood II May-14-2014
4 Becton Dickinson & Company II Feb-05-2015
5 Becton Dickinson & Company II Dec-19-2012
6 Becton Dickinson & Company II Dec-29-2009
7 Becton Dickinson & Company II Aug-12-2009
8 Becton Dickinson & Company II Jun-24-2009
9 Becton Dickinson & Company II Sep-18-2008
10 Becton Dickinson & Company II Apr-16-2008
11 Becton Dickinson & Company II May-24-2007
12 Becton Dickinson & Company II Apr-05-2007
13 Becton Dickinson & Company II Mar-03-2007
14 Biomet, Inc. III Jul-04-2007
15 Covidien LLC II May-31-2012
16 Ethicon, Inc. II Oct-22-2012
17 Harvest Technologies Corporation II Oct-17-2013
18 I-Flow Corporation II Sep-24-2009
19 Integra LifeSciences Corp. I Jun-22-2011
20 Integra LifeSciences Corp. d.b.a. Integra Pain Management II Oct-30-2015
21 Integra Pain Management II Aug-14-2008
22 Medela Inc. EF Division II Mar-11-2015
23 Merit Medical Systems, Inc. II Apr-03-2014
24 Merit Medical Systems, Inc. II Dec-02-2010
25 Merit Medical Systems, Inc. II Oct-15-2010
26 Merit Medical Systems, Inc. II Dec-14-2009
27 Merit Medical Systems, Inc. II Sep-21-2008
28 Nipro Medical Corporation II Mar-11-2010
29 Owen Mumford USA, Inc. II Jul-15-2015
30 Smith & Nephew Inc II Sep-20-2008
31 Synthes USA (HQ), Inc. II Sep-21-2011
32 Ulti Med, Inc. II Mar-31-2010
33 Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals II Dec-28-2009
34 Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals II Sep-24-2009
35 Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals II Jun-24-2009

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