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	Crack (1135)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/30/2020
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 asdvf015 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "the port needles changed.I was able to obtain a new and old port needle.The difference is the old port needles had blue caps and white clips.They were made in mexico.The new needles have white caps and clear clips and are made in china.Now that the newer needles are making there ways into all of the ahs infusion centers we are seeing more and more cracks." 2/28/2020- additional information received stated, "patient was accessed on (b)(6) and was infused with no leaking.Patient went home on a 5fu pump.When the patient woke up the next morning, the infusion had leaked all over the patient and also the bed.Patient called physician and was advised to go to the er in which to be de-accessed.Upon investigation of the port needle there was a fine crack on the y-site closest to the patient.This is commonly not the site that is accessed, but an additional orange cap is placed over this port that was not accessed.".

• 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: 9849026
• Report Number: 3006260740-2020-00880
• Device Sequence Number: 14310780
• 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
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/18/2020

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: ASDVF015
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2020
• Initial Report FDA Received Date: 03/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1