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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. BARD WINGED INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR

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BARD ACCESS SYSTEMS, INC. BARD WINGED INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Device Problems Retraction Problem (1536); Gas Leak (2946)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/09/2018
Event Type  malfunction  
Event Description
Patient had received iv pentamidine. After administration, nurse attempted to flush line with normal saline before locking with heparin. After attempting to check for blood return, the line pulled back intermittent blood with air bubbles present in syringe. Nurse flushed with a different normal saline syringe and noted the dressing was becoming wet as a leak was present. The dressing was removed, leak was noted between the connection of the wing and actual needle of the port needle. The needle was removed, and the patient was accessed again to heplock the line. Port needle leak. Huber needle. The set was discarded and unfortunately no identifying information was obtained. No harm to patient.
 
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Brand NameBARD WINGED INFUSION SET
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BARD ACCESS SYSTEMS, INC.
605 north 5600 west
salt lake city UT 84116
MDR Report Key8013568
MDR Text Key125285121
Report Number8013568
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 10/24/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/29/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/24/2018
Event Location Hospital
Date Report to Manufacturer10/29/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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