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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS STATLOCK IV SELECT MACRO 6IN WITH SMARTSITE START KIT 50 BOX; SET, ADMINISTRATION, INTRAVASCULAR
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BARD ACCESS SYSTEMS STATLOCK IV SELECT MACRO 6IN WITH SMARTSITE START KIT 50 BOX; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number N/A
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation, as the device was discarded after the event occurred.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 facility has had 3 cracked barrows on the statlock which caused a serious leak on one of the patients and issues on the others.This report addresses the first device.
 
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Brand Name
STATLOCK IV SELECT MACRO 6IN WITH SMARTSITE START KIT 50 BOX
Common Device Name
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
MDR Report Key8047665
Report Number3006260740-2018-03169
Device Sequence Number1807409
Product Code FPA
UDI-Device Identifier00801741082498
UDI-Public(01)00801741082498
Combination Product (Y/N)N
Initial Reporter StateTX
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) 11/07/2018
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 NumberIVK0124
Was Device Available for Evaluation? No
Event Location Hospital
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/17/2018
Initial Report FDA Received Date11/07/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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