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 following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a leaking y-site valve was confirmed.The product returned for evaluation was one 20ga x 0.75¿ miniloc safety winged infusion set with y-site.Usage residues were observed throughout the sample and the safety mechanism was engaged.An attempt to infuse water through the sample using a 12ml syringe revealed the sample to be patent to infusion and aspiration; however, during hydraulic pressurization, non-continuous leakage was observed emanating from the valve.Microscopic inspection of the sample revealed that the valve housing and septum appeared to be properly formed.A small, non-continuous leak was observed at the y-site valve.The product ifu states ¿needleless y-injection site valve may leak at certain pressures resulting in a small bead of fluid on the valve.¿ a lot history review (lhr) of asdtf012 showed five other similar product complaint(s) from this lot number.The complaints for this lot number (asdtf012) have been reported from the same facility.
Event or Problem Description
It was reported that the y-site on four needles leaked.No other information was provided.This report addresses the fourth needle.

• 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: 9287899
• Report Number: 3006260740-2019-03492
• Device Sequence Number: 16651867
• 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: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/06/2019

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: ASDTF012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2019
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2019
• Initial Report FDA Received Date: 11/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1