MAUDE Adverse Event Report: BARD ACCESS SYSTEMS STATLOCK IV SELECT MICRO 9IN BIFURCATED SMARTSITE 25 BOX; SET, ADMINISTRATION, INTRAVASCULAR

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 will not be returned to the manufacturer for evaluation, as the device is being retained by the reporting facility.A lot history review (lhr) review is not possible, as the device is manufactured using a unique serial number and not by lot number.A history review of serial number (b)(4) showed one other similar complaint(s) from this serial number.Both complaints for this serial number ((b)(4)) have been reported from one u.S.Facility.
Event or Problem Description
It was reported that the microbore extension sets are leaking at the y-site where the two lines split.It was stated this happened with two devices.This report addresses the first device.

• Brand Name: STATLOCK IV SELECT MICRO 9IN BIFURCATED SMARTSITE 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 Key: 8533343
• Report Number: 3006260740-2019-01097
• Device Sequence Number: 16751961
• Product Code: FPA
• UDI-Device Identifier: 00801741082061
• UDI-Public: (01)00801741082061
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K980992
• Number of Events Summarized: 1
• 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): 04/19/2019

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 Number: N/A
• Device Catalogue Number: IV0566
• Device Lot Number: JUCRX155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2019
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2019
• Initial Report FDA Received Date: 04/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1