MAUDE Adverse Event Report: BARD ACCESS SYSTEMS MINILOC SAFETY INFUSION SET 20G X 0.75IN WITH Y-SITE; 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)
Date of Event	08/19/2019
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 asdrf027 showed no other similar product complaint(s) from this lot number.- [mw5089302 (b)(4)].
Event or Problem Description
It was reported via medwatch " pt called from bathroom and states his "port came out".Came in to assess same and noted that night port had pulled part at y-site before lumens.Unable to clamp tubing due to same.Rt port needle and dressing still intact.Pt ad just gotten out of shower at this time and states he is unaware of how this happened as he does not remember pulling on same.Pt lied down in bed, de-accessed and re-access port without incident.Dr made aware of incident as well as picc team.Will continue to monitor same.".

• Brand Name: MINILOC SAFETY INFUSION SET 20G X 0.75IN WITH Y-SITE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9195150
• Report Number: 3006260740-2019-03036
• Device Sequence Number: 14393616
• Product Code: FPA
• UDI-Device Identifier: 00801741048043
• UDI-Public: (01)00801741048043
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K050600
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/15/2019
• Report Date (Section F): 08/21/2019

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: 0682034
• Device Lot Number: ASDRF027
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/19/2019
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2019
• Initial Report FDA Received Date: 10/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 08/21/2019