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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 410
Break 153
Detachment of device or device component 108
Power source issue 81
Protective measure issue 62
Needle, separation 49
Loose or intermittent connection 47
Component(s), broken 47
Bent 47
Crack 39
Device stops intermittently 36
Material separation 35
Unknown (for use when the device problem is not known) 33
Device operates differently than expected 31
Use of Device Issue 30
Difficult to remove 28
Leak 28
No Known Device Problem 24
Shielding failure 23
Failure to deploy 21
Needle, unsheathed 19
Difficult to insert 16
Material fragmentation 15
Fail-safe design failure 15
Manufacturing or shipping issue associated with device 15
Difficult or delayed activation 14
Retraction problem 14
Other (for use when an appropriate device code cannot be identified) 13
Failure to separate 13
No Information 13
Connection issue 12
Device, or device fragments remain in patient 12
Disconnection 11
Battery issue 11
Failure to advance 9
Fail-safe mechanism issue 9
Safety interlock(s) inadequate 8
Slippage of device or device component 8
Tip breakage 7
Material puncture 6
Loss of power 6
Disengaged 6
Failure to capture 6
Device or device fragments location unknown 6
Deployment issue 6
Device handling issue 6
No code available 5
Locking mechanism failure 5
Dislodged or dislocated 5
Fluid leak 5
Fracture 5
Improper or incorrect procedure or method 5
Sticking 4
Entrapment of device or device component 4
Difficult to open or close 4
Failure to disconnect 4
Device Issue 4
Physical resistance 3
Defective item 3
Foreign material present in device 3
Item contaminated during manufacturing or shipping 3
Contamination during use 3
Product quality issue 3
Device Difficult to Setup or Prepare 2
Overheating of device or device component 2
Unsealed device packaging 2
Particulates 2
Metal shedding debris 2
Foreign material 2
Colony forming units 2
Air leak 2
Dislodged 2
Mechanical jam 2
Tear, rip or hole in device packaging 2
Not Applicable 2
Medication Error 1
Unintended movement 1
Dull 1
Malfunction 1
Structural problem 1
Patient-device incompatibility 1
Biocompatibility issue 1
Buckled material 1
Device markings issue 1
Packaging issue 1
Positioning Issue 1
Extrusion 1
Material deformation 1
Improper flow or infusion 1
Incompatibility problem 1
Infusion or flow issue 1
Difficult to advance 1
Displacement 1
Disassembly 1
Failure to discharge 1
Device alarm system issue 1
Blockage within device or device component 1
Loss of or failure to bond 1
Component falling 1
Occlusion within device 1
Total Device Problems 1725

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