MAUDE Adverse Event Report: BARD ACCESS SYSTEMS MINILOC SAFETY INFUSION SET 20G X 1 IN 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	04/08/2020
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 asdvf012 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (asdvf012) have been reported from the same facility.
Event or Problem Description
It was reported "a patient who had been accessed several days before and was connected to a 5fu pump had leaking at the y-site when the patient returned to the oncology infusion area to be de-accessed." 04/13/2020: additional information received stated, " patient arrived on (b)(6) for an unplanned visit because hub of huber needle was cracked and chemotherapy was leaking onto patient.Patient drove 1 hour back to hospital to have site evaluated, port needle was removed, port was reaccessed with a new huber needle and a new 5fu pump was given to patient to come the following day for their scheduled pump disconnect.".

• Brand Name: MINILOC SAFETY INFUSION SET 20G X 1 IN 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: 9990899
• Report Number: 3006260740-2020-01501
• Device Sequence Number: 11872676
• Product Code: FPA
• UDI-Device Identifier: 00801741048029
• UDI-Public: (01)00801741048029
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K050600
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/23/2020

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: 0682010
• Device Lot Number: ASDVF012
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2020
• Initial Report FDA Received Date: 04/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR