MAUDE Adverse Event Report: BARD ACCESS SYSTEMS MINILOC PORT ACCESS KIT 20G X 0.75IN WITH Y-SITE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
It was reported the infusion set cracked and leaked infusion fluids.On (b)(6) 2020- additional information stated, "the issue is that the miniloc safety infusion set cracks and leaks chemotherapy drugs, approximately 24+ hours after being used with a pump.The crack occurs on the access port closest to the patient ( the one without wings) when a leur access device is placed.That is what causes the crack to occur.The crack is usually not seen or noticed initially but over time (approximately 24 hours later) will leak chemotherapy.".

• Brand Name: MINILOC PORT ACCESS KIT 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: 9884831
• Report Number: 3006260740-2020-01076
• Device Sequence Number: 19534115
• Product Code: FPA
• UDI-Device Identifier: 00801741044656
• UDI-Public: (01)00801741044656
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/26/2020

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: 2682034
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2020
• Initial Report FDA Received Date: 03/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1