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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. BARD MINILOC SAFETY INFUSION SET; SET, ADMINISTRATION, INTRAVASCULAR
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BARD ACCESS SYSTEMS, INC. BARD MINILOC SAFETY INFUSION SET; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Lot Number ASDR003
Device Problems Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)
Patient Problems Underdose (2542); Blood Loss (2597)
Event Date 12/04/2019
Event Type  Injury  
Event Description
A pt in our oncology dept was receiving chemotherapy (5fu-fluorouracil).This was part of a 48 hour long infusion.The pt was receiving the course of his chemo at home.The access device - bard miniloc safety infusion st lot asdr003 and ref #0682034 was used.The tubing separated from the hard plastic end (not broken, but slid out of the casing).As this was accessing a central line, the pt lost quite a bit of blood at home prior to being able to clamp off the access device.Furthermore, this resulted in a small quantity being wasted as the medication pump kept infusing.I have contacted bard via e-mail and left a voicemail to report.Fda safety report id# (b)(4).
 
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Brand Name
BARD MINILOC SAFETY INFUSION SET
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BARD ACCESS SYSTEMS, INC.
MDR Report Key9444786
MDR Text Key170659590
Report NumberMW5091539
Device Sequence Number1
Product Code FPA
Combination Product (y/n)Y
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 12/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Lot NumberASDR003
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/09/2019
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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