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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS STATLOCK IV SELECT MACRO 6IN SMARTSITE Y AND VALVE 25 BOX; SET, ADMINISTRATION, INTRAVASCULAR
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BARD ACCESS SYSTEMS STATLOCK IV SELECT MACRO 6IN SMARTSITE Y AND VALVE 25 BOX; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number N/A
Medical Device Problem Code Fluid/Blood Leak (1250)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 02/28/2020
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 during shift report oncoming rn noticed that iv connection port was broken off of patients y tubing.Per off-going rn it had been that way at the start of her shift.Per charting the line was flushed at 0059 but no iv medications were given that shift.Iv was removed and infection prevention was notified.No other information was provided.
 
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Brand Name
STATLOCK IV SELECT MACRO 6IN SMARTSITE Y AND VALVE 25 BOX
Common Device Name
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
MDR Report Key9856812
Report Number3006260740-2020-00904
Device Sequence Number14106227
Product Code FPA
UDI-Device Identifier00801741082047
UDI-Public(01)00801741082047
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K980992
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 03/19/2020
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 NumberN/A
Device Catalogue NumberIV0564
Was Device Available for Evaluation? No
Event Location Hospital
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/28/2020
Initial Report FDA Received Date03/19/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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