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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERLOC MAX I POWER-INJECTABLE INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR

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BARD ACCESS SYSTEMS POWERLOC MAX I POWER-INJECTABLE INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 19 GAUGE X .75 IN.
Device Problems Retraction Problem (1536); Fail-Safe Problem (2936)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/05/2016
Event Type  malfunction  
Event Description
After treatment, flushed implanted port and attempted to de-access port and safety device would not retract. Informed patient that safety device did not work but this would not affect her, safety device is to prevent nursing staff from needle stick.
 
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Brand NamePOWERLOC MAX I POWER-INJECTABLE INFUSION SET
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 north 5600 west
salt lake city UT 84116
MDR Report Key5642868
MDR Text Key44794054
Report Number5642868
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 05/06/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/10/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/01/2019
Device Model Number19 GAUGE X .75 IN.
Device Catalogue Number0141975
Device Lot NumberASAPS007
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/06/2016
Event Location Outpatient Treatment Facility
Date Report to Manufacturer05/06/2016
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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