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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. SAFESTEP HUBER NEEDLE SET 20 GUAGE O.75 INCH SET, ADMINISTRATION, INTRAVASCULAR

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BARD ACCESS SYSTEMS, INC. SAFESTEP HUBER NEEDLE SET 20 GUAGE O.75 INCH SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Lot Number ASFRF054
Device Problems Detachment of Device or Device Component (2907); Fail-Safe Did Not Operate (4046)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/02/2021
Event Type  malfunction  
Event Description
When deaccessing the needle from patient port the safety did not engage and the user ended up with the needle in one hand and the safety device in the other. Fda safety report id # (b)(4).
 
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Brand NameSAFESTEP HUBER NEEDLE SET 20 GUAGE O.75 INCH
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BARD ACCESS SYSTEMS, INC.
MDR Report Key12452699
MDR Text Key271032400
Report NumberMW5103821
Device Sequence Number1
Product Code FPA
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 09/07/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot NumberASFRF054
Was Device Available for Evaluation? No
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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