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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 6
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 8
BD
  SUBSTANTIALLY EQUIVALENT 18
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 3
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 2
FACET TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 3
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
KOFU FACTORY OF TERUMO CORP.
  SUBSTANTIALLY EQUIVALENT 2
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
NORFOLK MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
OHMEDA MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
OWEN MUMFORD
  SUBSTANTIALLY EQUIVALENT 1
PLEXUS BIOMEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 6
PORTEX, INC.
  SUBSTANTIALLY EQUIVALENT 3
POST MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 4
PYNG MEDICAL
  SUBSTANTIALLY EQUIVALENT 5
RETRACTABLE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
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 18
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 13
VITAL SIGNS, INC.
  SUBSTANTIALLY EQUIVALENT 2
VYGON CORP.
  SUBSTANTIALLY EQUIVALENT 1
WUXI YUSHOU MEDICAL APPLICANCES CO., LTD
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Detachment of device component 390
Break 126
Detachment of device or device component 96
Needle, separation 49
Component(s), broken 47
Loose or intermittent connection 41
Power source issue 41
Device stops intermittently 36
Bent 35
Unknown (for use when the device problem is not known) 33
Material separation 32
Protective measure issue 28
Device operates differently than expected 28
Use of Device Issue 25
Difficult to remove 23
Shielding failure 22
Failure to deploy 21
No Known Device Problem 20
Needle, unsheathed 19
Difficult to insert 16
Fail-safe design failure 16
Material fragmentation 13
Other (for use when an appropriate device code cannot be identified) 13
Retraction problem 13
Device, or device fragments remain in patient 12
No Information 12
Battery issue 11
Failure to advance 9
Fail-safe mechanism issue 9
Difficult or delayed activation 9
Failure to separate 8
Safety interlock(s) inadequate 8
Tip breakage 7
Disconnection 7
Slippage of device or device component 7
Device or device fragments location unknown 6
Loss of power 6
Disengaged 6
Failure to capture 6
Deployment issue 6
Material puncture 6
No code available 5
Dislodged or dislocated 5
Locking mechanism failure 5
Fracture 5
Entrapment of device or device component 5
Fluid leak 4
Sticking 4
Device Issue 4
Improper or incorrect procedure or method 4
Product quality issue 3
Contamination during use 3
Physical resistance 3
Connection issue 3
Device handling issue 3
Leak 3
Foreign material present in device 3
Defective item 3
Overheating of device or device component 2
Colony forming units 2
Component falling 2
Dislodged 2
Mechanical jam 2
Air leak 2
Metal shedding debris 2
Particulates 2
Not Applicable 2
Foreign material 2
Tear, rip or hole in device packaging 2
Corrosion 1
Device inoperable 1
Failure to sense 1
Migration of device or device component 1
Infusion or flow issue 1
Difficult to open or close 1
Structural problem 1
Buckled material 1
Component missing 1
Unintended ejection 1
Difficult to flush 1
Loss of or failure to bond 1
Disassembly 1
Occlusion within device 1
Extrusion 1
Unsealed device packaging 1
Device remains implanted 1
Medication Error 1
Material Protrusion 1
Failure to power-up 1
Material deformation 1
Unintended movement 1
Size incorrect for patient 1
Dull 1
Blood pooling 1
Failure to disconnect 1
Displacement 1
Insufficient flow or underinfusion 1
Device alarm system issue 1
Malfunction 1
Device damaged prior to use 1
Total Device Problems 1436

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