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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
  1.  K011757  EXEL COMFORTPOINT INSULIN PEN NEEDLE
  2.  K022406  EXEL SECURETOUCH SAFETY VACULET BLOOD COLLECTION S ...
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
  1.  K011757  EXEL COMFORTPOINT INSULIN PEN NEEDLE
  2.  K022406  EXEL SECURETOUCH SAFETY VACULET BLOOD COLLECTION S ...
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 327
Break 115
Detachment of device or device component 65
Needle, separation 49
Component(s), broken 47
Device stops intermittently 36
Unknown (for use when the device problem is not known) 33
Bent 30
Material separation 28
Power source issue 26
Device operates differently than expected 23
Shielding failure 22
Failure to deploy 21
No Known Device Problem 20
Needle, unsheathed 19
Difficult to remove 18
Fail-safe design failure 16
Difficult to insert 16
Use of Device Issue 15
Other (for use when an appropriate device code cannot be identified) 13
Retraction problem 12
Device, or device fragments remain in patient 12
Material fragmentation 11
Battery issue 11
No Information 10
Failure to advance 9
Difficult or delayed activation 9
Safety interlock(s) inadequate 8
Failure to separate 8
Tip breakage 7
Slippage of device or device component 7
Disconnection 7
Disengaged 6
Failure to capture 6
Loss of power 6
Material puncture 6
Device or device fragments location unknown 6
Deployment issue 6
Protective measure issue 5
Locking mechanism failure 5
Improper or incorrect procedure or method 4
Device Issue 4
Loose or intermittent connection 4
Fracture 4
Fail-safe mechanism issue 4
Dislodged or dislocated 4
Foreign material present in device 3
Device handling issue 3
Entrapment of device or device component 3
Contamination during use 3
Product quality issue 3
Sticking 3
Metal shedding debris 2
Tear, rip or hole in device packaging 2
Physical resistance 2
Dislodged 2
Colony forming units 2
Air leak 2
Fluid leak 2
Foreign material 2
Leak 2
Overheating of device or device component 2
Particulates 2
Not Applicable 2
No code available 2
Medication Error 1
Improper flow or infusion 1
Infusion or flow issue 1
Material deformation 1
Mechanical jam 1
Unintended movement 1
Packaging issue 1
Extrusion 1
Connection issue 1
Difficult to position 1
Failure to power-up 1
Migration of device or device component 1
Occlusion within device 1
Difficult to flush 1
Device alarm system issue 1
Loss of or failure to bond 1
Component falling 1
Displacement 1
Crack 1
Disassembly 1
Failure to discharge 1
Defective item 1
Failure to disconnect 1
Dull 1
Malfunction 1
Structural problem 1
Device damaged prior to use 1
Component missing 1
Blood pooling 1
Insufficient flow or underinfusion 1
Device inoperable 1
Device remains implanted 1
Failure to sense 1
Size incorrect for patient 1
Total Device Problems 1198

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