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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 0632210
Device Problem Obstruction of Flow (2423)
Patient Problems Pain (1994); Discomfort (2330)
Event Date 03/26/2019
Event Type  malfunction  
Event Description
Infant pediatric patient accessed with a port-a-cath (pac) needle. Iv pump alarming downstream occlusion throughout the shift. The pac safety needle was retracting out of port, requiring reinforcement of the needle underneath the dressing. This was causing stress and pain for the patient.
 
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Brand NamePORT ACCESS NEEDLE
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BARD ACCESS SYSTEMS, INC.
605 north 5600 west
salt lake city UT 84116
MDR Report Key8486275
MDR Text Key141018455
Report Number8486275
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 03/27/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/05/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0632210
Device Catalogue Number0632210
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/27/2019
Event Location Hospital
Date Report to Manufacturer04/05/2019
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? No
Type of Device Usage

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