MAUDE Adverse Event Report: BARD ACCESS SYSTEMS MINILOC SAFETY INFUSION SET 22G X 0.75IN; 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 device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of asduf027 showed two other similar product complaint(s) from this lot number.The complaints for this lot number (asduf027) have been reported from the same patient.
Event or Problem Description
It was reported "pt.Uses miniloc 0632234 to access her powerport isp.She has lot # asduf027 where the tubing split approximately 1.5¿ from the hub.This is the third needle from this lot that has failed.She gets 2 bags of saline per day, and 4 iv medications.She confirmed a blood return and did not feel resistance when she infused." this report addresses the first needle.

• Brand Name: MINILOC SAFETY INFUSION SET 22G X 0.75IN
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10189377
• Report Number: 3006260740-2020-02198
• Device Sequence Number: 16352504
• Product Code: FPA
• UDI-Device Identifier: 00801741047602
• UDI-Public: (01)00801741047602
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K050600
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/24/2020

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: 0632234
• Device Lot Number: ASDUF027
• Was Device Available for Evaluation?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2020
• Initial Report FDA Received Date: 06/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1