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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 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
Detachment of device component 6
Device operates differently than expected 6
Crack 5
Fluid leak 5
No flow 5
Device markings issue 4
No Information 4
Device handling issue 3
Not Applicable 3
No Known Device Problem 3
Loose or intermittent connection 3
Needle, separation 2
No code available 2
Pumping issue 1
Misassembled by Users 1
Accessory incompatible 1
Device misassembled during manufacturing or shipping 1
Product quality issue 1
Difficult to remove 1
Replace 1
Sticking 1
Physical resistance 1
Cannula Guide, Needle Insertion Difficult 1
Blocked connection 1
Chemical issue 1
Excess flow or overinfusion 1
Leak 1
Incompatibility problem 1
Infusion or flow issue 1
Material integrity issue 1
Total Device Problems 85

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

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