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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device needle, hypodermic, single lumen
Regulation Description Hypodermic single lumen needle.
Product CodeFMI
Regulation Number 880.5570
Device Class 2


Premarket Reviews
ManufacturerDecision
  SUBSTANTIALLY EQUIVALENT 1
ABBOTT
  SUBSTANTIALLY EQUIVALENT 2
ABCO DEALERS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ARROW INTL., INC.
  SUBSTANTIALLY EQUIVALENT 4
ARTSANA S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
ATRION MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
AUTOSAFE-REFELX INC.
  SUBSTANTIALLY EQUIVALENT 1
B. BRAUN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 9
BD
  SUBSTANTIALLY EQUIVALENT 15
BEMIS HEALTH CARE
  SUBSTANTIALLY EQUIVALENT 2
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
BUSSE HOSPITAL DISPOSABLES, INC.
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 2
DAEJIN TECH MEDICAL MANUFACTURING CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DEROYAL
  SUBSTANTIALLY EQUIVALENT 1
DISETRONIC MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 4
EXELINT INTERNATIONAL CO
  SUBSTANTIALLY EQUIVALENT 2
EXELINT INTERNATIONAL CO.
  SUBSTANTIALLY EQUIVALENT 1
FEEL TECH
  SUBSTANTIALLY EQUIVALENT 2
GAINOR MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1
GISH BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
GREINER BIO-ONE
  SUBSTANTIALLY EQUIVALENT 5
HAGER WORLDWIDE, INC.
  SUBSTANTIALLY EQUIVALENT 1
HDC CORP.
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - KIT 1
ICU MEDICAL SALES, INC.
  SUBSTANTIALLY EQUIVALENT 4
JMS
  SUBSTANTIALLY EQUIVALENT 3
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 1
KENDALL
  SUBSTANTIALLY EQUIVALENT 13
M&M INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MANAN MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MARQUETTE
  SUBSTANTIALLY EQUIVALENT 2
MEADOX
  SUBSTANTIALLY EQUIVALENT 2
MED INSTITUTE, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDEX
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL DEVICE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDISYSTEM
  SUBSTANTIALLY EQUIVALENT 2
MEDLINE
  SUBSTANTIALLY EQUIVALENT 2
MEGADYNE MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MULTI-MED, INC.
  SUBSTANTIALLY EQUIVALENT 2
NIPRO CORP
  SUBSTANTIALLY EQUIVALENT 5
OHMEDA MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
PLEXUS BIOMEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 6
PORTEX, INC.
  SUBSTANTIALLY EQUIVALENT 2
POST MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 4
PYNG MEDICAL
  SUBSTANTIALLY EQUIVALENT 4
RETRACTABLE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
SAGE PRODUCTS
  SUBSTANTIALLY EQUIVALENT 4
SHANDONG WEIGAO GROUP MEDICAL POLYMER CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHANGHAI DOUBLE DOVE INDUSTRIAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHINA CORP.
  SUBSTANTIALLY EQUIVALENT 2
SHINCHANG MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SIMS
  SUBSTANTIALLY EQUIVALENT 1
SMITHS
  SUBSTANTIALLY EQUIVALENT 9
SPECIALIZED HEALTH PRODUCTS
  SUBSTANTIALLY EQUIVALENT 2
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 15
TRISTATE
  SUBSTANTIALLY EQUIVALENT 1
TYCO HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 2
ULTIMED, INC.
  SUBSTANTIALLY EQUIVALENT 2
UNITED STATES SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
VIDACARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 12
VITAL SIGNS, INC.
  SUBSTANTIALLY EQUIVALENT 2
VYGON CORP.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Detachment of device component 87
Component(s), broken 47
Break 44
Unknown (for use when the device problem is not known) 33
Needle, separation 24
Bent 23
Needle, unsheathed 19
Shielding failure 18
Other (for use when an appropriate device code cannot be identified) 13
Difficult to insert 12
Device, or device fragments remain in patient 12
Retraction problem 11
Material separation 11
Use of Device Issue 8
Tip breakage 7
Failure to advance 7
Detachment of device or device component 6
Disengaged 6
Failure to capture 6
Locking mechanism failure 5
Slippage of device or device component 4
Material puncture 4
Product quality issue 3
Difficult to remove 3
Loose or intermittent connection 3
Deployment issue 3
Device operates differently than expected 3
Device operational issue 2
No Known Device Problem 2
No Information 2
Device handling issue 2
Improper or incorrect procedure or method 2
Colony forming units 2
Air leak 2
Disconnection 2
Dislodged 2
Foreign material 2
Fracture 2
Displacement 1
Occlusion within device 1
Difficult to position 1
Component falling 1
Failure to discharge 1
Safety interlock(s) inadequate 1
Sticking 1
Size incorrect for patient 1
Device remains implanted 1
Leak 1
Packaging issue 1
Dislodged or dislocated 1
Extrusion 1
Infusion or flow issue 1
Material deformation 1
Difficult or delayed activation 1
Physical resistance 1
Defective item 1
Device or device fragments location unknown 1
Device damaged prior to use 1
Blood pooling 1
Device Issue 1
Dull 1
Malfunction 1
Total Device Problems 468

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

Recalls
Manufacturer Recall Class Date Posted
1 Becton Dickinson & Company II Feb-13-2012
2 Becton Dickinson & Company II May-13-2011
3 Becton Dickinson & Company II Dec-27-2010
4 Becton Dickinson & Company II Sep-20-2007
5 Becton Dickinson & Company II May-24-2007
6 Centurion Medical Products I Mar-15-2010
7 Churchill Medical Systems, Inc. II May-01-2012
8 Covidien LP I Nov-05-2008
9 Exelint International Co. I Jan-22-2010
10 Greiner Bio-One North America, Inc. II Feb-15-2013
11 Greiner Bio-One North America, Inc. II Jul-03-2012
12 Greiner Bio-One North America, Inc. II Nov-09-2011
13 Greiner Bio-One North America, Inc. II Aug-08-2011
14 Greiner Bio-One North America, Inc. II Sep-30-2008
15 Greiner Bio-One North America, Inc. II Sep-11-2008
16 Medical Device Technologies, Inc. II Jul-13-2010
17 Multi-Med, Inc. I Sep-29-2010
18 Multi-Med, Inc. I Jul-02-2010
19 Popper & Sons Inc III Feb-12-2008
20 Pyng Medical Corporation II Jun-28-2011
21 Stat Medical Devices, Inc. II Jul-24-2009
22 Terumo Medical Corporation II Jul-13-2011

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