MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 EZ HUBER 20GX1IN WITH Y-SITE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	SHW20-75YS
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/28/2020
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 reeu2830 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that while trailing the huber needles, the clinicians had a few leaks at the y-site hub as they were flushing at the end connection.The blue hub pops out a little and it leaks.The facility said they are unsure if it is due to pressure or another factor but stated their concern for patient and staff safety if it were to happen with chemo instead of just saline.

• Brand Name: EZ HUBER 20GX1IN WITH Y-SITE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 10880601
• Report Number: 3006260740-2020-20630
• Device Sequence Number: 14282201
• Product Code: FPA
• UDI-Device Identifier: 00801741089879
• UDI-Public: (01)00801741089879
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K040533
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/02/2020

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: SHW20-75YS
• Device Catalogue Number: SHW20-75YS
• Device Lot Number: REEU0560
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/28/2020
• Initial Report FDA Received Date: 11/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other