• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
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
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 10
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
Break 17
No flow 9
Crack 7
Fluid leak 7
Detachment of device component 6
Device operates differently than expected 6
Device handling issue 6
Product quality issue 5
Fracture 4
Device markings issue 4
No Information 4
Manufacturing or shipping issue associated with device 3
Mechanical jam 3
Not Applicable 3
Loose or intermittent connection 3
Device Issue 3
Incorrect device or component shipped 3
No Known Device Problem 3
Needle, separation 2
Nonstandard device or device component 2
Failure to flush 2
Bent 2
No code available 2
Material integrity issue 1
Accessory incompatible 1
Contamination during use 1
Excess flow or overinfusion 1
Leak 1
Difficult to remove 1
Replace 1
Sticking 1
Improper or incorrect procedure or method 1
Insufficient flow or underinfusion 1
Device contamination with blood or blood product 1
Failure to infuse 1
Device misassembled during manufacturing or shipping 1
Physical resistance 1
Cannula Guide, Needle Insertion Difficult 1
Blocked connection 1
Chemical issue 1
Device Contamination with biological material 1
Pumping issue 1
Misassembled by Users 1
Infusion or flow issue 1
Incompatibility problem 1
Total Device Problems 128

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 1 0 0 0 0 0 2 2 0
Class III 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 Integra LifeSciences Corp. d.b.a. Integra Pain Management II Jul-09-2015
3 Integra LifeSciences Corp. d.b.a. Integra Pain Management II Apr-29-2015
4 Kyphon Inc II Feb-05-2008
5 RM Temena GmbH II May-12-2014

-
-