Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS INC. HEMOSPLIT LT HEMODIALYSIS CATHETER 14.5F
  • 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
 

BARD ACCESS SYSTEMS INC. HEMOSPLIT LT HEMODIALYSIS CATHETER 14.5F Back to Search Results
Catalog Number 5733730
Device Problem Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/21/2014
Event Type  malfunction  
Event Description
It was reported there was leakage at the junction (white plastic component) between the extension and the catheter.
 
Manufacturer Narrative
A lot history review (lhr) of reyl0447 showed no other similar product complaint (s) from these lot numbers.The device has not been returned to the mfr, at this time, for eval.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
HEMOSPLIT LT HEMODIALYSIS CATHETER 14.5F
Manufacturer (Section D)
BARD ACCESS SYSTEMS INC.
salt lake city UT
Manufacturer (Section G)
BARD REYNOSA S.A. DE C.V.
blvd. montebello#1
parque industrial colonial
reynosa, tamaulipas
MX  
Manufacturer Contact
christy chandonia
605 north 5600 west
salt lake city, UT 84116
8015224969
MDR Report Key4376825
MDR Text Key5115901
Report Number3006260740-2014-00623
Device Sequence Number1
Product Code MSD
Combination Product (y/n)N
Reporter Country CodeTH
PMA/PMN Number
K030020
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign
Reporter Occupation Other
Type of Report Initial
Report Date 11/28/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/23/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number5733730
Device Lot NumberREXL0447
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Event Location Hospital
Date Manufacturer Received12/04/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/01/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
-
-