MAUDE Adverse Event Report: BARD ACCESS SYSTEMS MINILOC SAFETY INFUSION SET 20G X 0.75IN WITH Y-SITE (MEDEGEN NEEDLELESS INJECTI; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of asdrf034 showed fifteen other similar product complaint(s) from this lot number.The complaints for this lot number (asdrf034) have been reported from the same facility.
Event or Problem Description
It was reported that the miniloc w/ y-site was found to be "defective".(b)(6) 2019: additional information rec'd states that the port needle is leaking from the septum on the needleless valve on the y-site.It seems to be happening when nurses are drawing blood from a port and blood leaks out of the septum of the y-site valve.It was stated this has occurred with 16 devices.This report addresses the sixteenth device.

• Brand Name: MINILOC SAFETY INFUSION SET 20G X 0.75IN WITH Y-SITE (MEDEGEN NEEDLELESS INJECTI
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9176987
• Report Number: 3006260740-2019-03002
• Device Sequence Number: 16835058
• Product Code: FPA
• UDI-Device Identifier: 00801741048968
• UDI-Public: (01)00801741048968
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K050600
• Number of Events Summarized: 1
• 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): 10/10/2019

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: S02320-75
• Device Lot Number: ASDRF034
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2019
• Initial Report FDA Received Date: 10/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1