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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. SAFESTEP HUBER NEEDLE SET SET, ADMINISTRATION, INTRAVASCULAR

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BARD ACCESS SYSTEMS, INC. SAFESTEP HUBER NEEDLE SET SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 231006
Device Problem Difficult to Remove (1528)
Patient Problem Insufficient Information (4580)
Event Date 01/26/2021
Event Type  malfunction  
Event Description
Pt has infus-a-port, used many times, here for op blood draw/port flush/provider visit. Access with 20gx0. 75 in safestep huber needle set, (lot# asexfoob) ref# lh-0031 not issues with access, blood drawn, port flushed with ns & heparin per protocol. When went to remove hubar needle, when pulled upright, needle would not come out or dislodge from port. Had to place fingers away from base of disc and near base of pad & pull needle out, using the pad- safety needle concept not able to be observed.
 
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Brand NameSAFESTEP HUBER NEEDLE SET
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BARD ACCESS SYSTEMS, INC.
605 n. 5600
west salt lake city UT 84116
MDR Report Key11596179
MDR Text Key243464479
Report NumberMW5100429
Device Sequence Number1
Product Code FPA
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 03/16/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number231006
Device Catalogue NumberLH-0031
Device Lot NumberASEXF008
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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