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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS INC. HEMOSTAR LT HEMODIALYSIS CATHETER 14.5F; MSD
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BARD ACCESS SYSTEMS INC. HEMOSTAR LT HEMODIALYSIS CATHETER 14.5F; MSD Back to Search Results
Catalog Number 5833690
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/18/2014
Event Type  malfunction  
Event Description
The clip on the extension cord was broken.
 
Manufacturer Narrative
A lot history review (lhr) of rexh2115 showed no other similar product complaint(s) from these lot numbers.The device has not been returned to the manufacturer, at this time, for evaluation.
 
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Brand Name
HEMOSTAR LT HEMODIALYSIS CATHETER 14.5F
Type of Device
MSD
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 Key4366096
MDR Text Key5264711
Report Number3006260740-2014-00614
Device Sequence Number1
Product Code MSD
Combination Product (y/n)N
Reporter Country CodeTH
PMA/PMN Number
K051748
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
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number5833690
Device Lot NumberREXH2115
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Event Location Hospital
Initial Date Manufacturer Received 12/04/2014
Initial Date FDA Received12/22/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/01/2013
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;
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