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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, CORPORATE OFFICE BARD; HICKMAN
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C.R. BARD, CORPORATE OFFICE BARD; HICKMAN Back to Search Results
Catalog Number 0600654
Device Problems Crack (1135); Device Operates Differently Than Expected (2913); Material Integrity Problem (2978)
Patient Problems Therapeutic Response, Decreased (2271); Anxiety (2328); No Code Available (3191)
Event Date 07/13/2015
Event Type  Injury  
Event Description
Patient with a triple lumen subclavian permanent venous access device.Fluid leaking out of catheter from a pinhole in blue lumen upon flushing catheter by clinical staff.The catheter was requested to be retained for the manufacturer assessment under the guidance of the fda.However, the surgeon placing the new catheter did not retain the catheter with the pin hole.
 
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Brand Name
BARD
Type of Device
HICKMAN
Manufacturer (Section D)
C.R. BARD, CORPORATE OFFICE
730 central ave.
murray hill NJ 07974
MDR Report Key5007196
MDR Text Key23388799
Report Number5007196
Device Sequence Number1
Product Code LJS
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Not Applicable
Report Date 08/11/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number0600654
Device Lot NumberHUYC1696
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/11/2015
Distributor Facility Aware Date07/13/2015
Device Age5 MO
Event Location Hospital
Date Report to Manufacturer08/11/2015
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/13/2015
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age67 YR
Patient Weight111
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