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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS MINILOC SAFETY INFUSION SET 20G X 0.75IN SET, ADMINISTRATION, INTRAVASCULAR

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BARD ACCESS SYSTEMS MINILOC SAFETY INFUSION SET 20G X 0.75IN SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number N/A
Device Problem Activation Problem (4042)
Patient Problem No Patient Involvement (2645)
Event Date 09/17/2019
Event Type  malfunction  
Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation. A lot history review (lhr) of asczs0081 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported that the orange device came off and the needle left the safety base. No other information was provided.
 
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Brand NameMINILOC SAFETY INFUSION SET 20G X 0.75IN
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
Manufacturer (Section G)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
Manufacturer Contact
kelsey erickson
605 n. 5600 w.
salt lake city, UT 84116
8015225937
MDR Report Key9290428
MDR Text Key165443559
Report Number3006260740-2019-03495
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K050600
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/23/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/07/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberS02020-75
Device Lot NumberASCZS0081
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/21/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location Outpatient Treatment Facility
Date Manufacturer Received12/16/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/01/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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