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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 7
BAYLIS MEDICAL CO., INC.
  SUBSTANTIALLY EQUIVALENT 1
BD
  SUBSTANTIALLY EQUIVALENT 11
BIO-MED
  SUBSTANTIALLY EQUIVALENT 1
BIOMET
  SUBSTANTIALLY EQUIVALENT 4
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 1
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
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 3
SURGITEK
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES
  SUBSTANTIALLY EQUIVALENT 1
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 14
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
Foreign material present in device 101
Break 97
Detachment of device component 83
Device operates differently than expected 73
Fluid leak 66
Shielding failure 37
Leak 33
No Information 33
Crack 23
Needle, separation 23
Syringe, defective 21
Infusion or flow issue 21
Item contaminated during manufacturing or shipping 19
Delivered as unsterile product 19
No Known Device Problem 14
Failure to deliver 13
Use of Device Issue 11
Disassembly 10
Failure to advance 10
Inaccurate delivery 9
Detachment of device or device component 8
No flow 7
Material puncture 7
Unknown (for use when the device problem is not known) 6
Defective component 6
Disconnection 6
Mechanical issue 5
Device inoperable 5
Device markings issue 5
Defective item 4
Tear, rip or hole in device packaging 4
No code available 4
Improper or incorrect procedure or method 4
Component missing 4
Product quality issue 4
Slippage of device or device component 4
Sticking 4
Foreign material 4
Kinked 4
No display or display failure 4
Hole in material 4
Contamination during use 4
Material fragmentation 3
Packaging issue 3
Protective measure issue 3
Material deformation 3
Mechanical jam 3
Dislodged or dislocated 2
Fail-safe mechanism issue 2
Not Applicable 2
Device handling issue 2
Incorrect or inadequate test results 2
High test results 2
Difficult or delayed activation 2
Physical resistance 2
Failure to deploy 2
Loose or intermittent connection 2
Excess flow or overinfusion 2
Device expiration issue 2
Air leak 2
Bent 2
Blockage within device or device component 2
Burst 2
Difficult to remove 2
Retraction problem 2
User used incorrect product for intended use 2
Material separation 2
Particulates 2
Device Issue 2
Insufficient flow or underinfusion 2
Other (for use when an appropriate device code cannot be identified) 2
Fitting problem 1
Volume accuracy issue 1
Tip breakage 1
Stopcock valve, failure of 1
Out-of-box failure 1
Device contamination with blood or blood product 1
Blood pooling 1
Loss of power 1
Failure to prime 1
Device, or device fragments remain in patient 1
No device output 1
Unsealed device packaging 1
Material rupture 1
Inadequate storage 1
Spillage, accidental 1
Calibration error 1
Device clogged 1
Component incompatible 1
Connection error 1
Measurements, inaccurate 1
Dislodged 1
Deflation issue 1
Filling problem 1
Entrapment of device or device component 1
Difficult to insert 1
Inadequate instructions for healthcare professional 1
Loose 1
Moisture damage 1
Total Device Problems 1054

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 1 0 0 0 0 0 0
Class II 4 5 8 4 1 3 1 2 4 3 3
Class III 1 0 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 Jul-19-2017
5 Becton Dickinson & Company II Jun-09-2016
6 Becton Dickinson & Company II Feb-05-2015
7 Becton Dickinson & Company II Dec-19-2012
8 Becton Dickinson & Company II Dec-29-2009
9 Becton Dickinson & Company II Aug-12-2009
10 Becton Dickinson & Company II Jun-24-2009
11 Becton Dickinson & Company II Sep-18-2008
12 Becton Dickinson & Company II Apr-16-2008
13 Becton Dickinson & Company II May-24-2007
14 Becton Dickinson & Company II Apr-05-2007
15 Becton Dickinson & Company II Mar-03-2007
16 Biomet, Inc. II May-25-2016
17 Biomet, Inc. III Jul-04-2007
18 Covidien LLC II May-31-2012
19 Ethicon, Inc. II Oct-22-2012
20 Harvest Technologies Corporation II Oct-17-2013
21 I-Flow Corporation II Sep-24-2009
22 Integra LifeSciences Corp. I Jun-22-2011
23 Integra LifeSciences Corp. d.b.a. Integra Pain Management II Oct-30-2015
24 Integra Pain Management II Aug-14-2008
25 International Medsurg Connection, Inc. II Aug-04-2017
26 Medela Inc. EF Division II Mar-11-2015
27 Merit Medical Systems, Inc. II Apr-27-2017
28 Merit Medical Systems, Inc. II Apr-03-2014
29 Merit Medical Systems, Inc. II Dec-02-2010
30 Merit Medical Systems, Inc. II Oct-15-2010
31 Merit Medical Systems, Inc. II Dec-14-2009
32 Merit Medical Systems, Inc. II Sep-21-2008
33 Nipro Medical Corporation II Mar-11-2010
34 Owen Mumford USA, Inc. II Jul-15-2015
35 Smith & Nephew Inc II Sep-20-2008
36 Synthes USA (HQ), Inc. II Sep-21-2011
37 Ulti Med, Inc. II Mar-31-2010
38 Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals II Dec-28-2009
39 Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals II Sep-24-2009
40 Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals II Jun-24-2009

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