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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HEMOSTAR LT HEMODIALYSIS CATHETER 14.5F

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BARD ACCESS SYSTEMS HEMOSTAR LT HEMODIALYSIS CATHETER 14.5F Back to Search Results
Catalog Number 5833690
Device Problem Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/12/2014
Event Type  malfunction  
Event Description
It was reported there was a leakage of catheter extension where the clip was placed.
 
Manufacturer Narrative
A lot history review (lhr) of rexh2115 showed one other similar product complaint(s) from this lot number.The device has not been returned to the mfr, at this time, for eval.
 
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Brand Name
HEMOSTAR LT HEMODIALYSIS CATHETER 14.5F
Manufacturer (Section D)
BARD ACCESS SYSTEMS
salt lake city UT
Manufacturer (Section G)
BARD REYNOSA S.A. DE C.V.
blvd montebello #1
parque induistrtial colonial
reynosa, tamaulipas
MX  
Manufacturer Contact
christy chandonia
605 north 5600 west
salt lake city, UT 84116
80122469
MDR Report Key4352922
MDR Text Key5220335
Report Number3006260740-2014-00611
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
Initial Date Manufacturer Received 12/04/2014
Initial Date FDA Received12/18/2014
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;
Patient Age29 YR
Patient Weight50
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