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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device needle, conduction, anesthetic (w/wo introducer)
Regulation Description Anesthesia conduction needle.
Product CodeBSP
Regulation Number 868.5150
Device Class 2


Premarket Reviews
ManufacturerDecision
  SUBSTANTIALLY EQUIVALENT 1
ADVANCE MEDICAL DESIGNS, INC.
  SUBSTANTIALLY EQUIVALENT 1
B. BRAUN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 5
BALLARD MEDICAL PRODUCTS
  SUBSTANTIALLY EQUIVALENT 2
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 2
BD
  SUBSTANTIALLY EQUIVALENT 1
BUSSE HOSPITAL DISPOSABLES, INC.
  SUBSTANTIALLY EQUIVALENT 2
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 2
EPIMED
  SUBSTANTIALLY EQUIVALENT 6
HAVEL'S, INC.
  SUBSTANTIALLY EQUIVALENT 1
KENDALL
  SUBSTANTIALLY EQUIVALENT 6
KYPHON, INC.
  SUBSTANTIALLY EQUIVALENT 3
LIFE-TECH INT'L., INC.
  SUBSTANTIALLY EQUIVALENT 3
MANAN MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 4
PAJUNK GMBH
  SUBSTANTIALLY EQUIVALENT 15
Remington Medical, Inc.
  SUBSTANTIALLY EQUIVALENT 1
RUSCH, INC.
  SUBSTANTIALLY EQUIVALENT 1
SIMS
  SUBSTANTIALLY EQUIVALENT 1
SMITHS
  SUBSTANTIALLY EQUIVALENT 1
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
VYGON CORP.
  SUBSTANTIALLY EQUIVALENT 1
WILSON COOK MEDICAL
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No flow 35
Nonstandard device or device component 34
Product quality issue 34
Manufacturing or shipping issue associated with device 31
Break 27
Fluid leak 24
Crack 18
Fracture 17
Device handling issue 16
Mechanical jam 9
Device Issue 9
Incorrect device or component shipped 8
Patient-device incompatibility 8
Size incorrect for patient 7
Device misassembled during manufacturing or shipping 6
Device operates differently than expected 6
Detachment of device component 6
Improper or incorrect procedure or method 5
Difficult to remove 4
Device markings issue 4
No Information 4
Not Applicable 3
No Known Device Problem 3
Bent 3
Loose or intermittent connection 3
Needle, separation 2
Sticking 2
Failure to flush 2
Failure to Adhere or Bond 2
No code available 2
Pumping issue 1
Misassembled by Users 1
Material integrity issue 1
Infusion or flow issue 1
Physical resistance 1
Cannula Guide, Needle Insertion Difficult 1
Accessory incompatible 1
Contamination during use 1
Replace 1
Material fragmentation 1
Excess flow or overinfusion 1
Leak 1
Insufficient flow or underinfusion 1
Device contamination with blood or blood product 1
Failure to infuse 1
Device-device incompatibility 1
Incompatibility problem 1
Blocked connection 1
Chemical issue 1
Device Contamination with biological material 1
Total Device Problems 354

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 1 0 0 0 0 0 2 2 1 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 B. Braun Medical, Inc. II May-28-2014
2 Epimed International, Inc. II Oct-31-2016
3 Integra LifeSciences Corp. d.b.a. Integra Pain Management II Jul-09-2015
4 Integra LifeSciences Corp. d.b.a. Integra Pain Management II Apr-29-2015
5 Kyphon Inc II Feb-05-2008
6 RM Temena GmbH II May-12-2014

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