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 manufacturer has received the sample and will evaluate.Results are expected soon.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 two needles were leaking from the blue y-site valve.This report addresses the second needle.
Additional Manufacturer Narrative
This report address the sealed sample.The following were reviewed as part of this investigation: patient severity, complaint and lot history, applicable previous investigation(s), labeling, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a leak from the blue y-site valve was confirmed.The product returned for evaluation was two 20ga x ¾¿ miniloc infusion sets, w/ y-site.One sample was returned within the original sealed pouch and another was returned outside of packaging and contained blood-like residue within the extension tubing.A green injection cap was attached to the y-site luer on that sample.Gross visual evaluation of both devices was unremarkable.No potential damage, defect, or deformity was observed.Functional testing included flushing through both luer hubs of each sample and inspecting for leakage.A small drop of fluid was observed on the blue valved y-site luer of the used returned sample.No similar fluid droplet was seen on the other sample.Further infusion of the used sample using a stop-start technique, aspiration of fluid, and straight infusion of fluid, did not produce another droplet of fluid.No continuous leakage was seen during any of the testing procedures of either sample.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 two needles were leaking from the blue y-site valve.This report addresses the second 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: 9225644
• Report Number: 3006260740-2019-03304
• Device Sequence Number: 1573239
• 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,Followup
• Report Date (Section B): 11/26/2019

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: 10/04/2019
• Initial Date Received by Manufacturer: 10/02/2019
• Supplement Date Received by Manufacturer: 11/06/2019
• Initial Report FDA Received Date: 10/23/2019
• Supplement Report FDA Received Date: 11/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1