MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HUBER PLUS 20G X 0.75" NEEDLELESS Y SITE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/28/2020
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 reds1094 showed 68 other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the plastic packaging is deformed, which leads to the loss of sterility of certain needles.It was state that the valve on the y-site is also deformed causing leaking.It was stated this occurred with 40 needles.This report addresses 19 of 40.

• Brand Name: HUBER PLUS 20G X 0.75" NEEDLELESS 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: 10072696
• Report Number: 3006260740-2020-01783
• Device Sequence Number: 19002278
• Product Code: FPA
• UDI-Device Identifier: 00801741065637
• UDI-Public: (01)00801741065637
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K993848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 05/19/2020

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 Expiration Date: 04/30/2022
• Device Model Number: N/A
• Device Catalogue Number: 012034NY
• Device Lot Number: REDS1094
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2020
• Initial Report FDA Received Date: 05/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1