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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. POWER LOC MAX SET, ADMINISTRATION, INTRAVASCULAR

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BARD ACCESS SYSTEMS, INC. POWER LOC MAX SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 0141975
Device Problem Retraction Problem (1536)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/27/2018
Event Type  malfunction  
Event Description
Patient presents for port flush. Port accessed with good blood return and flushes well. Upon de-access, needle did not retract to safety mode.
 
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Brand NamePOWER LOC MAX
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BARD ACCESS SYSTEMS, INC.
605 north 5600 west
salt lake city UT 84116
MDR Report Key7402318
MDR Text Key104569972
Report Number7402318
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 03/29/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/06/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/28/2020
Device Catalogue Number0141975
Device Lot NumberASCNS0050
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/29/2018
Event Location Hospital
Date Report to Manufacturer03/29/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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