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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
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 09/18/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation, as the competent authority does not return devices.A lot history review (lhr) of asbts0184 showed no other similar product complaint(s) from this lot number.Device will not be returned.
 
Event or Problem Description
It was reported that miniloc needle showed leakage in the curvature of the needle during infusion.
 
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Brand Name
MINILOC SAFETY INFUSION SET 20G X 0.75IN
Common Device Name
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
MDR Report Key8004963
Report Number3006260740-2018-03034
Device Sequence Number1464014
Product Code FPA
UDI-Device Identifier00801741048784
UDI-Public(01)00801741048784
Combination Product (Y/N)N
Initial Reporter CountryBR
PMA/510(K) Number
K050600
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,other
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 10/25/2018
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
Operator of Device Health Professional
Device Model NumberN/A
Device Catalogue NumberS02020-75
Device Lot NumberASBTS0184
Was Device Available for Evaluation? No
Event Location Other
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/04/2018
Initial Report FDA Received Date10/25/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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