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U.S. Department of Health and Human Services

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

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BARD ACCESS SYSTEMS, INC. SAFESTEP SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number LH-0031
Device Problems Fluid Leak (1250); Material Puncture/Hole (1504); Reflux within Device (1522)
Patient Problem Insufficient Information (4580)
Event Date 02/23/2021
Event Type  malfunction  
Event Description
Patient was at home with continuous blina infusing. Mom noticed blood backing up into the line and noticed some leaking at the connection site. Once in the clinic and port needle was de-accessed, rn flushed needle and noticed saline squirting out of a hole near the plastic safety device of the needle. Patient had a delay in receiving his continuous infusion and had to experience another port needle access.
 
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Brand NameSAFESTEP
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BARD ACCESS SYSTEMS, INC.
605 north 5600 west
salt lake city UT 84116
MDR Report Key11527105
MDR Text Key241002812
Report Number11527105
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 03/03/2021,02/23/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberLH-0031
Device Catalogue NumberLH-0031
Device Lot NumberASEYF005
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/03/2021
Event Location Home
Date Report to Manufacturer03/19/2021
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 Unkown

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