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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
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 14
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 33
Nonstandard device or device component 29
Product quality issue 29
Manufacturing or shipping issue associated with device 26
Break 19
Fluid leak 19
Fracture 12
Device handling issue 12
Crack 11
Mechanical jam 9
Device Issue 9
Incorrect device or component shipped 8
Detachment of device component 6
Device misassembled during manufacturing or shipping 6
Device operates differently than expected 6
Patient-device incompatibility 4
Improper or incorrect procedure or method 4
Device markings issue 4
No Information 4
Not Applicable 3
No Known Device Problem 3
Loose or intermittent connection 3
Size incorrect for patient 3
Bent 3
Failure to flush 2
Failure to Adhere or Bond 2
Difficult to remove 2
Sticking 2
Needle, separation 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
Insufficient flow or underinfusion 1
Device contamination with blood or blood product 1
Failure to infuse 1
Blocked connection 1
Chemical issue 1
Device Contamination with biological material 1
Device-device incompatibility 1
Incompatibility problem 1
Replace 1
Material fragmentation 1
Excess flow or overinfusion 1
Leak 1
Accessory incompatible 1
Contamination during use 1
Total Device Problems 297

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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