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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 Burn, Thermal (2530)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
 
Event or Problem Description
It was reported that the patient is complaining that the gripper is leaking and burned patient.A of (b)(6) 2019 no further reports on the client¿s status have been reported.It was stated that two needles were noted to be leaking.This report addresses the first device.
 
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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 Key8634060
Report Number3006260740-2019-01455
Device Sequence Number1992772
Product Code FPA
UDI-Device Identifier00801741048784
UDI-Public(01)00801741048784
Combination Product (Y/N)N
Initial Reporter CountryCA
PMA/510(K) Number
K050600
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date (Section B) 05/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model NumberN/A
Device Catalogue NumberS02020-75
Was Device Available for Evaluation? No
Event Location Hospital
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/03/2019
Initial Report FDA Received Date05/22/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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