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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. POWERLOC MAX PORT ACCESS NEEDLE SET, ADMINISTRATION, INTRAVASCULAR

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BARD ACCESS SYSTEMS, INC. POWERLOC MAX PORT ACCESS NEEDLE SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 142075
Device Problem Retraction Problem (1536)
Patient Problem Needle Stick/Puncture (2462)
Event Date 02/26/2018
Event Type  malfunction  
Event Description
We have had many device failures. This is representative of the problems and additional numbers affected: safety mechanism did not engage during de-access. Employee stuck index finger while de-accessing huber needle placed at facility (huber needle did not retract). Manufacturer response for huber needle, power loc (per site reporter). Phone call with manufacturer r and d rep. Not happy with results of the call. Evaluating additional huber needle manufacturers.
 
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Brand NamePOWERLOC MAX PORT 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 Key7663230
MDR Text Key113170507
Report Number7663230
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 06/27/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/05/2018
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number142075
Device Lot NumberASBZS0067,ASCQS0049,ASCNS0156
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/27/2018
Device Age1 YR
Event Location Hospital
Date Report to Manufacturer07/02/2018
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? No
Type of Device Usage

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