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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 MINILOC SAFETY INFUSION SET 22G X 0.75IN WITH Y-SITE; SET, ADMINISTRATION, INTRAVASCULAR
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C.R. BARD, INC. (BASD) -3006260740 MINILOC SAFETY INFUSION SET 22G X 0.75IN WITH Y-SITE; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number S02322-75
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 12/04/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
 
Event or Problem Description
It was reported miniloc needle was found leaking fluid.No other information was provided.
 
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Brand Name
MINILOC SAFETY INFUSION SET 22G X 0.75IN WITH Y-SITE
Common Device Name
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
C.R. BARD, INC. (BASD) -3006260740
605 north 5600 west
salt lake city 84116
MDR Report Key11069273
Report Number3006260740-2020-21098
Device Sequence Number10923300
Product Code FPA
UDI-Device Identifier00801741048999
UDI-Public(01)00801741048999
Combination Product (Y/N)N
Initial Reporter StatePA
Initial Reporter CountryUS
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 Other Health Care Professional
Type of Report Initial
Report Date (Section B) 12/10/2020
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 Model NumberS02322-75
Device Catalogue NumberS02322-75
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 12/04/2020
Initial Report FDA Received Date12/23/2020
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 Other;
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