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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 1 IN; SET, ADMINISTRATION, INTRAVASCULAR
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BARD ACCESS SYSTEMS MINILOC SAFETY INFUSION SET 20G X 1 IN; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number N/A
Medical Device Problem Code Fluid/Blood Leak (1250)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 03/24/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of asdqs0271 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (asdqs0271) have been reported from the same facility in (b)(6).
 
Event or Problem Description
It was reported miniloc with leakage through infusion line.No other information was provided.
 
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Brand Name
MINILOC SAFETY INFUSION SET 20G X 1 IN
Common Device Name
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
MDR Report Key10138337
Report Number3006260740-2020-02026
Device Sequence Number3637092
Product Code FPA
UDI-Device Identifier00801741048722
UDI-Public(01)00801741048722
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 distributor,other
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 06/10/2020
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 Expiration Date02/28/2022
Device Model NumberN/A
Device Catalogue NumberS02020-10
Device Lot NumberASDQS0271
Was Device Available for Evaluation? No
Event Location Hospital
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/18/2020
Initial Report FDA Received Date06/10/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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