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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. PORT ACCESS NEEDLE; SET, ADMINISTRATION, INTRAVASCULAR
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BARD ACCESS SYSTEMS, INC. PORT ACCESS NEEDLE; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 0142075
Device Problem Break (1069)
Patient Problem No Code Available (3191)
Event Date 02/01/2020
Event Type  malfunction  
Event Description
During completion and flush of etoposide, break in line was noted by mop.The break was seen under the blue cap on patient's port access.An estimated 3-4ml of output was noted before clamping both ends of line and stopping flush.Md was notified about break in line over the phone.At this time, rn began to de-access and re-access patient for flush to be completed per md verbal order.Once patient was de-accessed, the line was placed in biohazard bag to be held for follow up.Patient was re-accessed and etoposide flush was finished.Patient stable and was de-accessed with 100:1 heparin before sending home.I was the flex rn helping with this patient.I am writing this to follow up with the equipment that was defective.Device was a 20gauge x 0.75 in.Power loc max power injectable infusion set.Manufacturer bard.
 
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Brand Name
PORT ACCESS NEEDLE
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BARD ACCESS SYSTEMS, INC.
605 north 5600 west
salt lake city UT 84116
MDR Report Key10008787
MDR Text Key189301488
Report Number10008787
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/29/2020
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number0142075
Device Catalogue Number0142075
Device Lot NumberASDUF021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/24/2020
Event Location Hospital
Date Report to Manufacturer04/29/2020
Type of Device Usage N
Patient Sequence Number1
Patient Age365 DA
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