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U.S. Department of Health and Human Services

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

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BARD ACCESS SYSTEMS, INC. PORT ACCESS NEEDLE SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number LH-0033
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 08/17/2020
Event Type  malfunction  
Event Description
Medical oncology used a safestep 19g x 0. 75 inch huber needle to access patient. No issues accessing or obtaining blood. Upon deaccessing patient, the safety feature did not work. Needle removed from port side but was not protected as the safety piece completely came off. No harm occurred, or needlestick.
 
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Brand NamePORT 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 Key10540104
MDR Text Key207135400
Report Number10540104
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 Risk Manager
Type of Report Initial
Report Date 08/26/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberLH-0033
Device Catalogue NumberLH-0033
Device Lot NumberASEPS0043
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/26/2020
Event Location Hospital
Date Report to Manufacturer09/16/2020
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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